Despite these challenges, medical device companies have always been adept with the latest technology and innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most Innovative Medical Devices Companies 2018.”

1. www.insightscare.com
September 2018
GroupKDiagnostics:
Transforming Patient Care with
Accurate, Fast, &Affordable Diagnostics
1
T
0
H
E
MOST INNOVATIVE
MEDICALDEVICES
COMPANIES
2018
Brianna Wronko
C E O

2. Weuse moredata.
More data means better solutions.
w w w .t h i n k d a t a s m a r t . c o m

4. From the
Editor
nnovation in technology always comes with a promise of
future development possibilities.A new technology launched
Itoday, is old news tomorrow. The healthcare sector is no
exception. Technologies like the Internet of Things,Artificial
Intelligence, or Additive Manufacturing, have hadtremendous
disruptive effects on how we treat patients. They have also
influenced the ways we keep track of our health daily.
AI has brought about a paradigm shift in the healthcare sector,
powered by the increased availability of medical data & rapid
development of analytics techniques. AI can be useful to process
various types of healthcare data, structured and unstructured. Main
disease areas that use AI tools consist of cancer, cardiology, and
neurology. Diagnostic tools, genetics, electro-diagnosis,
monitoring, physiology, disability evaluation, mass screening, and
others are some of the prominent subsections that can deploy AI
effectively. This technology is largely being used in diagnosis,
since its early days.
“We should think about AI the way we think about patient care- as
a continuum, spanning care areas and disease states.”- Dr. Mark
Michalski, MD, Executive Director of the Massachusetts General
Hospital.
AI can use erudite algorithms to ‘learn’ features from an enormous
volume of healthcare data, and then use the acquired insights to
assist clinical practice. This ability of AI can be further enhanced
by equipping it with learning and self-correcting, so as to increase
the accuracy of the feedback. An AI based system can assist the
physicians; by providing informed medical information from
previous literature, and clinical practices, to offer proper patient
care. Additionally these systems can help reduce diagnostic and
therapeutic errors. All these advantages and assistance is provided
in real time, thus providing fast and calculated decisions to the
physicians.
In spite of AI attracting substantial attention in medical research
and healthcare sector, the technology has been facing tangible
issues while its implementation. The two major hurdles that AI is
currently facing are the regulations that bind the technology,
security concerns, and data exchange. The efficacy and safety of
AI systems require standards for their assessment, which current
regulations lack. AI based systems require a continuous training or
upgrading by clinical studies that are published daily, in order for
them to work well. However due to the deficit in data supply and
sharing, the initially deployed training with historical data is all the
systems have to offer. Tackling these issues is a must before the
healthcare sector can use and unleash the full potential of Artificial
Intelligence in providing state-of-the-art patient care!
Artificial
Intelligence:
Bringing about a
Paradigm Shift
in Patient Care
Sayali Rane

5. Insights SuccessMedia Tech LLC
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September, 2018
Corporate Of ces:
Copyright ©2018 Insights Success, All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in
any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights Success.
Reprint rights remain solely with Insights Success.
Editor-in-Chief Pooja M. Bansal
Managing Editor Ashwini Deshmukh
Executive Editors Sayali Rane
Shane Gomez
Contributors Aishwarya, Datta
Visualiser David King
Art &Design Director Amol Kamble
Associate Designer Rahul Kavanekar
Co-designer Priyanka, Shweta
Art &Picture Editor Paul Belin
Jayant Khanna
Senior Sales Manager Amy Jones
Business Development ManagerMark Williams
Sales Executives
Kelli Thomas, Bill Thompson, John Smith
TechnicalHeadSwapnilPatil
TechnicalSpecialist Amar, Vivek, Pratiksha
Digital Marketing Manager Marry D’Souza
SME-SMO Executives
Prashant Chevale, Uma Dhenge
ResearchAnalyst Chidiebere Moses
Circulation Manager Robert, Tanaji
Database Management Stella Andrew
TechnologyConsultant David Stokes

6. Revolutionary Medical
Devices Transmuting
the Healthcare Space
edical devices play a decisive role in the healthcare industry. To carry out the smallest of tasks in this
sector, it is important to employ the right device and technology; from a major surgical operation to
Mprimary health monitoring, devices are present for everything.
Medical device companies develop a plethora of products such as wheelchairs, defibrillators, pacemakers, stents,
infusion pumps, etc. The medical device industry is highly structured, and companies must continuously invest in
research and development in order to preserve a competitive superiority. The future of the global medical device
market looks bright with prospects in public and private hospitals. The worldwide medical device arcade is projected
to reach an estimated $409.5 billion by 2023.
Despite these challenges, medical device companies have always been adept with the latest technology and
innovations happening in the sector. Keeping this in mind, we bring you the in-depth profiles of- “The 10 Most
Innovative Medical Devices Companies 2018.” These 10 are the bellwether medical devices companies, with
diverse product ranges, strong performance, and significant revenues.
On the cover we have showcased, Group K Diagnostics. The company manufactures a modular, point-of-care, paper
microfluidic diagnostic device with a mobile app that reads the device’s outputs, and quantifies results for physicians
to make informed diagnoses within 20 minutes of seeing a patient.
Flipping through the pages you will find Motiv Inc. that excels in developing simple wearable devices that can make
people’s lives better; Misceo, is a pioneer that provides cutting-edge real-time cardiac monitoring and analysis for
Hospital and clinics; BioSerenity, it is a fast growing company which combines high tech engineering, innovative
technologies, medical development, and big data analytics to provide wearable medical device solutions; Trexo
Robotics, this company is a pioneer in delivering wearable robotics for children with disabilities to assist with
mobility; Zenflow is developing an office-based, less invasive, long lasting, and easy to learn treatment to relieve the
symptoms of BPH.
We have also featured Oxitone Medical Ltd., Vascular Dynamics, Beyonics, and Lutech Industries; as some ofthe
leading medical device manufacturing companies.
We also bring you an expert’s view on a fiery topic namely ‘AI Is Starting to Change Radiology,’ written by Dr.
Enhao Gong, who is the founder of Subtle Medical.
Our in house editorial team has also put together interesting articles, on trending topics in the healthcare space.
So, flip through the pages of our magazine and treat yourself with the technological innovations trending in the
medical device industry!

8. Transforming Patient Care
with Accurate, Fast, &
Aflordable Diagnostics
Group K
Diagnostics:
38
Telemedicine
Telemedicine-
The Fastest Growing
Segment of Emerging
Services in Healthcare
Industry
Organs-On-Chips
Organs-On-Chips:
APotential Drug-testing
Alternative Approach
2
30
CXO
CoverStay
10
Transforming
Radiology
AI is Starting to
Change Radiology,
for Real

9. t ts18
BioSerenity:
Technology at
the Service of
Healthcare
20
Misceo Grand
Technology:
Ushering towards
the Next Generation
Telemedicine
Technology
26
Motiv:
Providing Subtle,
Sleek &
Sophisticated
Wearable Devices
36
Trexo
Robotics:
Delivering Futuristic
& Innovative
Pediatric Wearable
Robotic Devices
42
Zenflow:
Driving the Future
of BPH Relief with
Innovative
Solutions

10. When you deliver
superior service, rely on
superior equipment.
Ensure a comfortable birth day, everyday.
w w w . g e h e a l t h c a r e . c o m

12. We provide
a revolutionary
application of point-of-care
diagnostics
BriannaWronko
CEO

13. Group K
Diagnostics:
Transforming Patient Care with
Accurate, Fast, & Aflordable
Diagnostics

14. The clinical decision making
process is affected by a series
of sequential steps; lab testing
being one of the most vital ones. In
spite of this, providers are struggling to
effectively receive and manage lab test
results, with a significant lag between
patient appointments and results.
During her time in a Philadelphia HIV
clinic, Brianna Wronko saw a
troubling case involving a pregnant
mother diagnosed with HIV. Due to the
delay in receiving the patient’s results,
the patient remained on her
medication, which was detrimental to
both her and the fetus. She could not
be reached by phone or mail, therefore
making a change to her medication
impossible until she walked into the
clinic several months later. Without
the necessary immediate action in
response to her test results, the mother
and child were left with the possibility
of severe physical complications and a
high cost of future care.
This is an extreme case, but such
setbacks can be avoided with
immediate testing and results. That is
when Wronko started working on a
product with a thoughtful perception of
the big picture. She focused on the
manufacturing, ease of use,
marketability, and adoption in the
current healthcare infrastructure, and
then scaling the big picture down until
she developed the current design, and
platform to support those elements.
That is when Group K Diagnostics,
Inc. was born. Today the company is
working seamlessly under Wronko’s
guidance. She serves as the CEO of
Group K.
Group K manufactures a modular,
point-of-care, paper microfluidic
diagnostic device with a mobile app
that reads the device’s outputs, and
quantifies results for physicians to
make informed diagnoses within 20
minutes of seeing a patient.
The Journey of anIdealistic
Organization
Group K Diagnostics has developed
from a research prototype to a reality.
The company foresees bringing to
market this transformative technology
as early as 2019. Upon the opening of
a larger wet lab space, separate
manufacturing space, expanded
administrative offices, and the
completion of initial clinical trial
testing by year end 2018, the company
will begin scaling into the healthcare
marketplace. Comprised of a seasoned
team of engineers, operators and
business executives matched with
world class advisors, Group K
Diagnostics continues to change the
path within the diagnostics industry.
The Young & Dynamic Leader
Wronko brings seven years of research
experience in microfluidics and
Our Multi-Diagnostic
Point-of-Care test allows
providers to take immediate
therapeutic action based
on results
Cover Story
immunology to design and
manufacture Group K’s paper
microfluidic devices. Wronko has a
BSE in Bioengineering from the
University of Pennsylvania.
Her experience with FDA and
governmental approval processes from
her time at Five Eleven Pharma and
GSK has been instrumental for
streamlining the pre-clinical, clinical,
and FDA processes. Now, with a team
of research engineers and technicians
for device production and
development, Wronko focuses on
overall technological development and
company vision.
Discrete Services & Products
Group K Diagnostics’ technology has
two components, hardware and
software:
The Hardware Component- the paper
microfluidic device is designed to
support over 60 tests and counting. The
design of the devices’ channels, sample
deposition region, and detection
regions—as well as the instructions for
use—remain constant, while the
reagents used in the detection regions
change to support different diagnostic
tests. This allows healthcare providers
to learn one protocol for testing instead
of having to remember several
different ones. The device also features
a QR code to note expiration date, test
identity, and lot number; a barcode to
associate the test with a patient and
transmit results to the electronic health
record; and a color panel for the
computer vision feature of Group K’s
mobile app to reference and normalize
color based on ambient lighting.
The Software Component- is comprised
of several portals targeting various
stakeholders in the healthcare system.
The mobile app is used to walk the
provider through the steps associated
with using the device, collect results,
inform diagnoses, and record patient
data in the Electronic Health System.
The flow of the app includes a login
page and patient confirmation followed

15. by image acquisition. A picture of the
device’s detection regions is acquired,
and through computer vision, image
processing, and AI- analysis it
produces produce quantified measures
that inform diagnoses and are recorded
in the EHR. Through the company’s
patient app or patient portal login,
patients can access their results and
transfer them from hospital to hospital.
Finally, combining everything together,
there is an additional portal available to
hospital administrators. Group K
Diagnostics’ hospital portal also has
epidemic tracking and hospital
preparedness applications with
anonymized patient data. By analyzing
the type of tests being ordered, and the
corresponding results, hospital systems
can identify epidemics and better
prepare with optimized inventory
purchasing and staffing. With big data
analysis, Group K Diagnostics can
track the severity and geographic
location of disease and predict where
disease will spread. This information
can be used to increase hospital’s
preparedness for epidemics and general
disease.
For example, Group K’s Liver
Function Test (LFT) results in a
measurement for ALT (amongst five
other metabolites) in terms of units per
liter which is used to evaluate one
aspect of liver function. The web app
would display anonymized data for
providers, for example to see if a Liver
Clinic was effectively managing
medication switches for liver disease
patients. The mobile app has patient
and provider portals. With 36% of
abnormal results never communicated
to patients, the app eliminates this
miscommunication and allows the
patient to have their full diagnostic test
history stored in their app. The
provider portal organizes the
diagnostic tests, and immediately
transfers the results to the EHR so
information is never lost.
Group K’s technology can be used in
specialty and primary care centers. The
clinical use of the company’s
technology does not impose any
additional training on nurses and
physicians, so these personnel can
easily adopt its technology into their
workflow, while eliminating the
existing time they spend at the end of
their day calling patients or release
results to their patients.
We ofler
a paper-based diagnostic
tool, to cut down the
cost of lab diagnosis

16. Vision & Mission of Group K Diagnostics
Group K Diagnostics offers a clever, simple solution for the
slow, inefficient, and costly laboratory testing that sets
today’s standard for 77% of all patient diagnoses. Iterating
about Microfluidics in the diagnosis laboratory Wronko
says, “We admit that applying microfluidics to the
laboratory testing problem is not novel. Research labs have
designed and implemented prototypes but fail to make cost
effective manufacturing processes and complimentary
software.” Group K intends to revolutionize diagnostic
testing by having solved the age old problem of adapting
microfluidics to laboratory diagnostics by a streamlined,
patient and physician suitable diagnostic.
Capturing Markets with Innovation
Having started out in a strong research vertical, Group K
Diagnostics is blazing a new path forward, in point of care
diagnostic testing. The immediate markets the company is
addressing, include LFTs ($972 million), comprehensive
metabolic panels (CMPs, $5.4 billion), and complete blood
counts (CBCs, $4.1 billion). The most important facet of
Group K’s technology, driving its value, is the time it takes
for diagnostic testing.
On average, existing laboratory testing results take 10 days
to return to a provider, despite 77% of diagnoses are only
completed with lab results. This delay loses patients,
transforms acute cases to chronic cases, and increases
patient costs. Additionally, this testing procedure costs
patients $15-100 per test unless they follow strict insurance
guidelines. The current standard for diagnostic testing and
laboratory testing takes too long, during which patients are
lost to follow-up, acute cases, can become chronic, thus
increasing patient costs.
Relative to the market, Group K Diagnostics is unique in
that its product is low cost, requires less than 20 minutes for

17. results, does not require training or refrigeration, can be completed in office, and
supports multiple tests. The company states, “Our biggest competitor- Abbot’s
iStat- requires training and refrigeration and cannot be completed in office.”
Matchless Solution to Point-Of-Care Diagnostic Testing
Group K’s technology reduces the time to results from 10 days to 20 minutes for
$8-12. The diagnostic test can be completed within a patient appointment,
leading to patient retention, patient diagnosis and immediate clinical action, as
well as reduced costs for patients. The technology improves patient care by
lowering the cost of laboratory diagnostic testing, supporting immediate clinical
action, giving patients the rights to their results, and better preparing hospitals to
respond to epidemics or clinic wide issues. The cost of the device falls below that
for laboratory testing reimbursement today, which makes Group K’s platform
more accessible to low resource clinics and patients.
The firm’s modular, microfluidic device, and mobile app with computer vision
and AI revolutionize diagnostic testing by providing quantified results within
minutes. This allows physicians to take immediate clinical action. This
technological platform will support over 60 tests in the future with liver function,
comprehensive metabolic panels, and complete blood counts as its initial tests.
The fast response time of the technology provides results within a single
appointment, allowing immediate clinical action to be taken, so that time
sensitive and communicable cases are better treated as well as controlled.
The distinct patient portal gives patients access to their result records, so all
abnormal results are immediately reported, as well as overseen and given by a
provider in the moment. Improving hospital preparedness for epidemics allows
patient experience to improve, protecting patients against infectious diseases or
outbreaks.
Another intriguing feature of the product is that it is easy to use and does not
require additional training. It also doesn’t require refrigeration, and can be
completed in office. This gives patients’ direct access to their results, eliminating
any miscommunications that might occur in the case of 36% of abnormal results
that currently go unreported. All these elements have led to seamless integration
of Group K Diagnostics’ product in to the physician, and nurse workflow.
Instigating a Groundbreaking Change in Healthcare
The numerous advantages of the product will ease payer demands, and allow the device to be used by
physicians in specialty or primary clinics, without access to on-site labs, and needing urgent & frequent
results. In addition to increasing accessibility to laboratory testing to low resource regions and patients,
Group K’s product will improve time to diagnosis for all users. The need for immediate results and clinical
action is crucial for improving treatment and preventing acute cases from becoming chronic.
Another key feature of its software is the provider and patient portals. It will allow patients to receive and
keep records of their results ensures that abnormal results are communicated and also transferred easily when
a patient transfers providers. Group K Diagnostics’ platform prevents this miscommunication, and helps
protect patients and providers. Another revolutionary application of the company’s software component is
epidemic tracking using anonymized patient data.
The medical diagnostics industry continues to change rapidly and with its revolutionary application of point-
of-care diagnostics, Group K Diagnostics believe that it will continue to stay ahead of the trends by
continuously making advancements within its technologies.

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19. Company Name Management Brief
Beyonics
beyonics.com
Scott D.Smith
CEO
Beyonics is one of the leading precision parts manufacturers
offering complex integrated manufacturing services such as
precision metal stamping, innovative mold design and
fabrication.
BioSerenity
bioserenity.com
Pierre Frouin
Founder & CEO
BioSerenity is a fast growing company which combines high
tech engineering, innovative technologies, medical
development, and big data analytics to provide wearable
medical device solutions.
Group K Diagnostics
groupkdiagnostics.com
Brianna Wronko
CEO
Group K Diagnostics, manufactures a modular, point-of-care,
paper microfluidic diagnostic device with a mobile app that
reads the device’s outputs, and quantifies results for physicians
to make informed diagnoses within 20 minutes of seeing a
patient.
Lutech Industries
lutechmedical.com
Leanna Vachula
President
Lutech Industries Inc. brings together innovative, cutting-
edge technology with cost conscious strategies; by
providing affordable, quality medical equipment that will
allow providers to care for their patients effectively.
Misceo
misceo.io
Mahesh Galgalikar
CEO
Misceo Grand Technology is a pioneer that provides cutting-
edge real-time cardiac monitoring and analysis for Hospital
and clinics for both in-patient monitoring andAmbulatory out-
patient monitoring using a single medical device platform.
Motiv
mymotiv.com
TejashUnadkat
CEO
Curt von Badinski
Co-founder & CTO
Motiv is a company that excels in developing simple
wearable devices that can make people’s lives better.
Oxitone Medical Ltd
oxitone.com
Leon Eisen
CEO
The Oxitone watch is the world’s first wrist pulse oximeter
without a fingertip probe enabling comfortable patient
monitoring of blood oxygen level and pulse rate anytime,
anywhere.
Trexo Robotics
trexorobotics.com
Manmeet Maggu
CEO
Trexo Robotics is a pioneer in delivering wearable robotics
for children with disabilities to assist with mobility; it
provides state-of-the-art products at an affordable price.
Vascular Dynamics
vasculardynamics.com
Ed Roschak
CEO
Vascular Dynamics Inc. is pioneering endovascular
baroreflex amplification (EVBA) to advance the treatment
of hypertension to bring a better quality of life to patients
who are resistant to conventional treatments.
Zenflow
zenflow.com
Nick Damiano
CEO
Zenflow is developing an office-based, less invasive,
long lasting, and easy to learn treatment to relieve the
symptoms of BPH.

20. he rise in the global population
Thas triggered an increase in
healthcare costs and a number
of unmet medical needs; technology
offers solutions on a number of levels,
reducing time, and space limitations.
One such company that aids this
problem by providing wearable
medical device solutions is
BioSerenity. Established in January
2014, the company is located within
the Brain and Spine Institute, at the
heart of the largest university hospital
in France: la Pitié-Salpêtrière in Paris,
with offices across France, China and
the United-States. The company is
internationalizing and expanding, with
the workforce of more than hundred
employees. It offers solutions for many
applications in diagnosis, monitoring,
and clinical trials.
BioSerenity is a fast growing company
which combines high tech engineering,
medical development, and Artificial
Intelligence to solve four key problems
by:




Allowing long term recordings
without increasing patient’s burden,
while significantly reducing
hospitalization costs.
Reduce diagnosis errors that are
due to lack of data or
misinterpretation errors.
Help patients to receive the
appropriate treatment as fast as
possible.
Reduce patient cohorts needed for
clinical trial by providing more
accurate data.
The company first started providing
Smart Healthcare Solutions with the
focus on Epilepsy and has since
expanded to Cardiology, Sleep
disorders monitoring, and Urology.
BioSerenity’s solutions have helped
diagnose over twelve thousand patients
and it has recently raised 20 million
dollars to support its growth. It tackles
these challenges with the help of a rich
ecosystem of partners. The company
has collaborated with patient groups,
academic centers, hospitals, and
industry to come up with futuristic
medical devices.
Spearheading BioSerenity
Bioserenity was instituted by Pierre
Frouin, who is currently the CEO of
the company. He holds a Master’s
degree, in IT Engineering and a MBA
from INSEAD, which he leverages to
lead BioSerenity towards becoming
one of the fastest growing medical
devices company. Pierre has worked in
the medical industry throughout Asia,
Europe and North America, for almost
his entire career. Pierre’s experience in
the pharmaceutical industry and the
medical diagnostics industry has
helped him understand that point of
care diagnostics was going to be
critical for the development of
personalized medicine.
Distinctive Products and Solutions
that BioSerenity Offer
The Neuronaute is the first solution
developed for the diagnosis of epilepsy
based on the use of a smart textile, a
Pierre Frouin
Founder &CEO
We combine high-tech
engineering, medical
development, and
analytics, to deliver full
stack precision
medicine solutions
“
“
18 / September 2018 /
BioSerenity:
Technology at the Service of Healthcare

21. Profile-1
mobile application, and a cloud
platform. The system is designed to
make it possible to record
physiological parameters continuously,
including electroencephalography
(EEG), and in an outpatient setting.
The goal is to give neurologists a tool
to get to the diagnosis of epilepsy
faster by recording patients in their
home environment or in any hospital
bed on the long term basis. The signals
are then parsed by an A.I. assistant to
help identify digital biomarkers or
anomalies. Its A.I., called Serena,
learns from the interpretation of
Neurologists (machine learning) how
to identify critical elements in the EEG
that are linked to a pathology. For each
recording, the A.I. analyzes thesignals,
and helps neurologists focus on
important periods of the EEG signals.
The aim is primarily to save the
physician’s time by not having to
review lengthy periods of raw signal.
The company is now working on
Cardiology, Urology, Sleep Disorders,
and Pregnancy Monitoring. It has
developed a Cloud platform that allows
it to deploy Medical Device and
Mobile Apps powered with A.I. across
the globe. The company works closely
with doctors and researchers; this
allows it to focus on what is most
needed, instead of what is most trendy;
to bring to the medical community the
best tools possible that help patients.
BioSerenity believes that this approach
leads to faster adoption, and a leaner
iteration process. It has also setup a
strong regulatory team and culture; an
expertise that is often missing in tech
startups.
Awards and Accolades BioSerenity
has Received
With over twelve national and
international awards, BioSerenity has
received the support of doctors and
patients from all around the world. The
company is the recipient of the
International Innovation Awards, the
World Wide Innovation Challenge,
Innovact Award, Connectitude
Program, and many more.
Technology Trends in the Medical
Device Industry
Currently there are two major
technological revolutions undergoing
that have the potential to change the
landscape of Medical Device industry
that include:
 IoT (Internet of Things) is allowing
for remote monitoring of devices
and much shorter cycles of
improvements.
 Artificial Intelligence is assisting
physician in their daily practice.
IoT is already helping millions of
devices being better maintained, while
Artificial Intelligence is still in its
infancy.
Future Perspective of BioSerenity
The medical device industry was
historically separated and often in the
shadow of the pharmaceutical industry.
Now that the Medical device industry
is in the spot light, the future will
generate more cooperation between the
two industries. BioSerenity’s next
product launch is going to be in Sleep
Disorders with an ambulatory
polysomnography assessment solution.
The Somnonaute is a medical device
project aiming to allow a full
polysomnography exam in a medical
sleep analysis setting. In order to allow
a full exam to be recorded, a connected
cap, shirt, and pants are required.
Recorded measurements include
electroencephalogram,
electrocardiogram, electromyograms,
pulse oximetry, movement,
positioning, and breathing.
/ September 2018 / 19

22. Misceo Grand
Technology:Ushering towards the Next Generation
Telemedicine Technology
here is a growing demand for a
system that can monitor all
Tessential body vitals and
activities of the patient usually
monitored in ICU and help in Cardiac
events prevention, diagnosis, post-
operative care and ongoing
management of patients through non-
invasive monitoring. Silicon Valley-
based Misceo Grand Technology is a
pioneer that provides cutting-edge real-
time cardiac tracking and analysis for
Hospital and clinics for both in-patient
monitoring and Ambulatory out-patient
monitoring using a single medical
device platform.
Misceo helps Hospitals to extend their
services beyond their premises. It
provides a connected healthcare
solution to decentralize existing
healthcare infrastructure and
coordinate patient care services
between clinics at remote locations and
hospitals.
Misceo/The company first came into
existence as a software analytics
company for the diagnosis of
congenital heart defects using acoustic
analysis of heart but soon jumped into
Healthcare IoT industry and started
building its H/W product line for a
tele-ICU market. Misceo is working to
close the gap between inpatient and
outpatient monitoring by developing a
seamless medical device platform that
could scale from hospitals to homes.
The company intends to disrupt the
home healthcare market and optimize
healthcare delivery with the help of its
medical device solution and advance
cloud analytics expertise.
About the Leading Light and His
Sight
The company was incepted in 2013 by
its visionary Founder and dynamic
CEO, Mahesh Galgalikar. He holds a
Master’s degree in Electrical and
Electronics Engineering from
Rochester Institute of Technology, NY
and has more than eight years of vital
experience in medical technology
development. He is the pillar of
strength for Misceo and the principal
inventor behind its flagship technology.
According to the CEO, today, everyone
wants to reap quick benefits without
understanding the harsh reality that this
industry is one of the slowest moving
sectors regarding product market
adoption and especially in regulatory
requirements. “Medical community is
very rigid when it comes to adoption of
new technologies. Due to rigorous
standards laid down by FDA, it’s
always a lengthy process to get the
product ready for market,” asserts
Mahesh. “Our focus is very
straightforward and clear, build a
product which is centered on the end
users need and deliver the best quality
possible in the least amount of time.”
Significant Facets of its Product
Company’s flagship product is a
portable one that provides accessible
and insightful details related to a heart
Mahesh Galgalikar
Founder &CEO
We provide connected
healthcare solution to
decentralize existing
healthcare
infrastructure
“
“
20 / September 2018 /

23. ailment in a technologically superior
manner that too at low cost and in
simple & accurate terms. Apartfrom
this, their product is unique in much
sense. It offers:
 Continuous Monitoring: Misceo
Access is the only continuous long-
term multi-sensor ambulatory
monitor to be in the market
 EHR Integration: Misceo Unity
infrastructure will seamlessly
integrate with hospitals EHR
systems to deliver hassle free
solution
 Error-proof: The ergonomic design
of Misceo Access eliminates
common errors due to ECG patch
misplacement
 Reusable: Misceo Access canbe
used time and again (Electrode
patches are the only disposable
element)
 Efficient Procedures: Monitoring
device moves with the user, so
transitions from one procedure or
location to the next are seamless in
Hospitals
 Multi-parametric Status
Monitoring: Provides Continuous 6
Lead ECG, PPG, O2 Sat, Body
Temperature & Activity
 Virtual Oversight: AI lead oversight
for continuous patient monitoring
reduces the burden on physicians,
cardiologists, and technicians in
Hospital and thus assists in analyzing
patient data and alert generation
The Scenario of Medical Device
Industry
Hospital readmission is a primary
concern these days. If hospitals don’t
reduce preventable 30-day
readmissions, they stand to lose a
substantial amount of revenue as per
Hospital readmission reduction
program administered by CMS in
2012. An effective telemedicine service
is the solution to this problem.
Although, there are many MCT
devices available, but none assist the
hospitals in a way that can reduce
financial losses. Thus there is a dire
need for a system that would scale
effectively from inpatient monitoring
scenarios to outpatient monitoring and
provide more clinical grade
information to help cardiologist come
up with a diagnostic solution rather
than just alert creation. High
cumulative consumer costs (due to
non-reusability), dependence on the
device company for raw data retrieval,
the company technician’s accurate
collection and reporting of raw data,
and generation of a summary report are
some of the numerous disadvantages
which current medical devices possess.
To alter this scenario, Misceo
developed its wireless solutions that
continuously monitor multiple body
vitals and therefore provide arrhythmia
burden, but can also wirelessly send
critical arrhythmic events in real time
for timely diagnosis and treatment.
Future Outlook
There was a time when the medical
device industry was more focused on
curative measures and understanding
the progression of a disease. Today, it
is moving towards preventive
healthcare as more and more emphasis
is given on disease prevention. Soon,
technology like AI will assistscientists
to unlock many mysteries towards the
cause of disease prevention.
“We feel with the technology in
development at Misceo, we would be
able to have a better understanding of
human cardiac conditioning and
progression of various symptoms in
various cardiac and COPD conditions
which would help us prevent significant
medical conditions,” concludes the
CEO. “Company intends to scale the
solution for simply hospital scenario to
a full-fledged home healthcare solution
for chronic patient management by
2019.”
/ September 2018 / 21

24. Telemedicine
The Fastest Growing Segment of Emerging
Services in Healthcare Industry
lthough initially considered by some of the critics as ‘far away in future’ and ‘still
in experimental stages’, telemedicine is a living and thriving reality today. India,
Awith masses of talented people, is a nation of underdeveloped physical
infrastructure. Telemedicine provides a potential opportunity to leapfrog steep challenges
faced by such existing inadequacies in physical infrastructure for healthcare services.
Telemedicine is a system where doctors and patients can share information in real time from
faraway locations one computer system to another. They can have patient’s check-up
through medical devices and can also capture the readings for diagnosis. Telemedicine is
widely applicable in patient care, public health, and administration, hospitals and education.
System and Network Set-up
Telemedicine technology comprises software and peripheral components such as web
camera and dish antenna to receive the signals or a broadband connection. There is an
interface created between hardware, software and communication channels with satellites or
internet to ultimately bridge two people in different locations.
Utilities for Patients
Patients and doctors can interact via the webcam-based interface, and communicate for
diagnosis and treatment. When patients need to consult with their primary care physicians,
they can submit the request in the system. The physicians placed at a remote location are
immediately notified and can respond by activating an audio-visual interface. Even if the
concerned physician is not available the request is transferred to other doctors in the
national network.
Unlike in general hospitals where they may have to wait for an appointment, telemedicine
provides instant access to doctors. The service can be made available to patients with
22 / September 2018 /

25. / September 2018 / 23

26. medical consultation off hours. Especially with the critical necessity of specialist doctors who may not be available locally.
They can help monitor the rare and chronic conditions of the patient.
Telehealth for Common Man
The terms telemedicine and telehealth are many times used as synonyms. But some of the experts are of opinion that
telemedicine is the physician focused term and tele-health is used to refer all health professionals. Hospitals or healthcare
organizations involved in implementing telehealth or telemedicine will be able to distinguish between the two as technology
becomes advanced and popular for the common man.
Benefits of Telemedicine
The biggest benefit is the availability of expert specialist to all patients in remote locations if the need arises. Patients can
avoid the cost of transportation or avoid wasting time in traffic with video consultations from the comforts of his home.
Individuals engaged by their work can also schedule a consultation during a break or even after work hours and will not
miss any day of work for the sake of minor health problems. As specialists are rare and short in supply, patients like
children or elderly people can use telemedicine solutions without the struggle for their specific health concerns.
Recent Trends for Adopting New Technology
Patient self-monitoring was a big trend recently for using the medical records and health-related data with modern devices
and smartphones available. For example, small digital devices are available today which can track patient ECG’s and send
the report to doctors, providing an invaluable tool for healthcare professionals to monitor cardiovascular activity.
Hospitals and insurance companies are using emerging cloud technology to store electronic medical records. These are
accessible to patients also who can see their test results and medical reports online. One of the main reasons why it has
enjoyed success is because of increased customer satisfaction numbers. Telemedicine and related mobile applications are
much more efficient in data collection and making research much more reliable with the well-documented database.
Implementing a Telemedicine Project
Telemedicine program should be that helps in identifying the specific needs of a community. These needs can be
susceptibility to certain ailments or nutritional deficiencies as a result of cultural or social bias. Geographical variations also
communities may have a large number of citizens who need diabetes or nutrition related counseling.
Training of Staff for Patients’ Acceptance
Well-trained professionals, related to both technical aspects and health care emergencies, must be available with adequate
knowledge, experience, and job-related skills. The team implementing telemedicine project should ensure that the standard
procedure is followed while using the equipment.
Patient’s acceptance is an important parameter where patients can feel comfortable using the facilities and that can save
time for other social activities. In addition to connecting patients with a primary care physician, telemedicine can facilitate
access to specialists and super-specialists and also to the team of experts in particular kind of disease. Telemedicine saves
time and money by avoiding travel for both doctors and patients. It also allows patients to remain in their communities,
which means they will fill prescriptions, purchase healthcare accessories etc.
Emerging Frontiers in Telemedicine
Telemedicine technology is emerging as one of the fastest growing segments in the healthcare industry. Many organizations
are taking it as a preferred destination to park their money and investment is increasing steadily. The global telemedicine
market has shown the growth by around 18% CAGR. Readily accessible care, reduced healthcare costs, productive
workforce, and enhanced patient experience are some of the main reasons why telemedicine is becoming popular. Ashifting
economic background, developments within the healthcare industry, responsive and conducive legislative environment have
already created fertile ground for telemedicine to grow. Smartphones and internet-capable mobile devices may be the
driving factor behind the success of telemedicine. The gadgets and the growing popularity of artificial intelligence and the
internet of things are taking the possibilities to new heights. Out of healthcare delivery methods intended to play a greater
role in healthcare, telemedicine is the most promising one.
24 / September 2018/

28. Motiv
:
Providing Subtle, Sleek &Sophisticated
Wearable Devices
orm factor, durability, stylish
Fdesign and the integration of
leading-edge technology for
precise data collection are some of the
factors that define a superior wearable
product. One company that considers
these factors with precision and craft
products that people want to wear is
Motiv Inc.
Motiv Inc. is a breakthrough wearable
technology company designing
products that fit seamlessly into
people’s lives. Motiv Ring was
announced in January 2017 at the
Consumer Electronics Show and
officially began shipping in September.
Its debut garnered a terrific response
and glowing reviews from a multitude
of prominent media outlets. It has a
user-centric design which is both
comfortable and state-of the-art. Motiv
Ring is not currently a medical device;
however, the company considers this
form a stepping stone to evolve as a
true medical device company in the
future.
An Innovative, Accomplished, &
Design Driven Company
Motiv began when Co-founder and
CTO Curt von Badinski had a light-
bulb moment that convinced him to use
his tech expertise for a small and
lightweight fitness tracker that could
make people’s lives better. Curt is a
serial tinkerer, inventor, entrepreneur
and businessman. As a mechanical
engineer, he worked on various
projects and quite a few IT companies;
it was during that time that he realized
that his work-obsessed and sleep-
deprived lifestyle was less than ideal.
He wanted to get a device that could
allow him to track his sleep and health
better, he tried what was on the market
and those options didn't work for him,
and he was inspired to make a
seamless experience for people in a
ring form factor. “Innovation in
wearables doesn’t happen overnight.
Change is typically the result of a lot of
research and development followed by
difficult engineering challenges.
Building an amazing and capable team
is one of the best ways to get there,”
says von Badinski.
Progressive, Passionate, &
Experienced Leader ofMotiv
Tejash Unadkat is the CEO of Motiv;
he joined the company in 2017. He
oversees all elements of the business
including sales expansion, product
development, people management, and
company growth. Under his leadership,
Motiv has expanded its operating
system support (now on both Android
and iOS), retail distribution channels
(including Amazon and Best Buy),
platform compatibility (Alexa, Apple
Health and Google Fit), and a slew of
health partnerships (including Pear
Sports, Plus 3 and Lindora.) Tejash
Tejash Unadkat
CEO
Curt von Badinski
Co-founder & CT O
We provide subtle,
sleek, and
sophisticated wearable
devices that are
comfortable and people
want to wear
“
“
26 / September 2018/

29. believes in building products that are
useful to the people twenty-four hours
of the day, seven days a week — across
the health, wellness, access, security,
and payments spectrum.
Idiosyncratic Features of Motiv Ring
Motiv Ring is the first medical device
that blends in; this smart ring tracks
heart rate, activity, and sleep. Motiv
Ring is waterproof up to 165 feet. At
less than 0.1 inches thick, it is about as
thin as a nickel and weighs less than a
penny. The titanium-shelled ring holds
a charge for three days, and connects to
the Motiv App available on both iOS
and Android. It is about one tenth the
size of its competitors, which makes it
a people’s choice.
While the wearable space is a crowded
one, Motiv’s two biggest
differentiators are the form factor and
sensor data. The company has spent a
substantial amount of time and effort
on the development of its form factor
while working their way down to the
technology. Its considerably small size
makes Motiv Ring an engineering
marvel. Motiv has developed a product
with components that are smaller than
a grain of sand. Motiv Ring is entirely
custom made, right from the sensors,
circuit boards, and battery. Motiv has
taken the technology of a wrist-worn
device and miniaturized it into a
2.4mm-thick ring. Finding the
components — batteries, sensors,
titanium shells that could
accommodate its small size — was a
challenge. Despite the challenges the
form factor posed, it is hugely resonant
with Motiv's customers who appreciate
that the minimal, not clunky look, and
that their wrists are free once again for
watches, bracelets, or nothing at all.
The Benefits of a Finger-Worn
Device
As far as sensor data is concerned,
Motiv Ring has advantages over wrist-
based devices. Tattoos or even arm hair
can affect the quality of heart rate data
while wearing a wristband. These
problems are far less common on the
finger and palms, which also helps
with heart rate data collection. The
company’s ring fitting process, with
seven unique sizes, allows users to get
the right fit. A proper fit is imperative
for collecting the best data.
Additionally, Motiv Ring uses a
benchmark of active minutes, rather
than steps, to measure heart health.
These active minutes are tracked any
time one is active for more than 10
minutes. Thus, “cheater” steps - those
back and forth to the fridge or to the
couch - are not rewarded as activity.
This benchmark keeps its users honest
and their hearts healthy. Apart from
this the ring is always with the user -
durable, stylish, comfortable, and
lightweight; it’s motivation wrapped
around one’s finger.
Motiv Inc.’s Future Perspective
Motiv is continuing to expand its
functionalities, partnerships,
distributions, and integrations on a
monthly basis. This continued
momentum is important for the
company’s growth. Motiv just
announced its Google Fit integration in
July, and will be announcing a series of
healthcare partnerships with leading
health tech companies in the coming
months. Later this fall, the company
will be introducing another version of
its beloved ring and will enter into the
biometrics space.
/ September 2018 / 27

30. Everything wedo
is aimed at
ImprovingLives
w w w . a c o r d a . c o m

31. QUALITYHEALTHCARE
AFFORDABLEPLANS
w w w . f h c p . c o m

32. APotential Drug-testing Alternative Approach
Organs-On-Chips
ew drugs, medications and therapies are discovered
every day. Pharmaceutical companies spend enormous
Namounts of funds and time on the research and
development of novel drug targets strategies. In spite of all the
effort not all the medications and therapies make it to the market.
There is a dire need of a solution to accelerate drug research.
For quite some time now cell cultures in petri dishes have been
used to test the efficacy of new therapy, but this method does not
give us a full proof knowledge of the working of the therapy. Cell
cultures in-vitro do not react to drugs in a way similar to how
they would retort inside the human body. Moreover, animal
testing is a time-consuming, expensive, and is not satisfactory
enough to prove the efficiency of a treatment on humans.
Numerous drugs and therapies pass the animal tests, but end up
being proved detrimental to humans; because traditional animal
models often do not precisely mimic human pathophysiology.
More than $2 billion are spent on a single compound being
clinically tested. Meanwhile, countless animal lives are also lost.
For these reasons, there is an exigent need for alternative ways to
fast-track the development of new drugs and improve
personalized medicine.
To address this pressing issue scientist have come up with a new
technology “organs on chip.” These are Cell cultures, often in
3D, that use microfluidics to mimic the way a tissue or part of an
30 / September 2018 /

33. organ work. From breathing lungs to beating hearts,
organs-on-chips are some of fieriest novel tools for human
biology research. Although these devices may bear closer
semblance to computer constituents than human body parts,
scientists have now produced working models for a whole
assortment of organs, including the lung, the liver, and even the
female reproductive system.
Scientists hope to use these devices to model disease
and ease drug development. Organ on chip research
has already permitted us to create numerous microfluidic
chips that can partly mimic organ function. Multi-organs on chip
might also allow us to observe the side effects of drugs on different
organs, and not keep the study restricted to those organs that the
treatment targets. The goal is to be able to link a maximum of parts
in order to, allow one and all to have access to customized
treatments by using their one’s own cells to test them, which is
termed as personalized medicine.
Functioning of Organ-on-Chip
It is improved computer microchip manufacturing method to
engineer microfluidic culture devices that reiterate the
microarchitecture and functions of living human organs. These
micro devices, propose a prospective substitute to traditional animal
testing. Each organ chip constitutes a clear flexible polymer
approximately the size of a computer memory stick that encloses
hollow microfluidic channels lined by living human organ specific
cells. These cells are interfaced with a human endothelial cells lined
on an artificial vasculature; mechanical forces can be applied to this
set up to mimic the physical microenvironment of living organs,
which includes the peristalsis-like deformations in the intestine and
breathing motions in lung.
They are fundamentally three-dimensional, living cross-sections of
chief functional components of complete living organs. The
translucent nature of the device, allows scientists to view the inner
working of the human cells without invading the living body. With
their capability to host and combine the diverse cells and tissues,
organ chips present an idyllic microenvironment to study molecular
and cellular activities that bring about human organ function and
imitate human specific disease conditions, as well as pinpoint new
therapeutic targets in vitro.
This device, intended to mimic whole-body physiology, controls
fluid flow and cell viability while simultaneously permitting real-
time observation of the cultured tissues and facilitates analysis of the
intricate connected biochemical and physiological responses across
ten different organs. This complete “Human Body-on-Chips”
method can be used to predict human pharmacokinetic and
pharmacodynamics reactions of drugs in vitro.
/ September 2018 / 31

34. Lungs on Chips
Today the primary goal of the healthcare space is the
development of novel solutions to treat pulmonary diseases.
Studies have shown that lung diseases are the fifth largest
cause of death, and are predicted to be the third by 2020, all
around the world. To address this issue it is important to
develop strategies and drugs that can be made available to
the public quickly. In this circumstance, using lungs on
chips to facilitate the development of new treatments has
shown a potential way ahead.
The device mimics a living, breathing human lung on a
microchip. The device, about the size of a toffee, acts much
like a lung in a human body. It is made using human lung
cells and blood vessel cells. At present scientist are still
unable to mimic the exact entire lung on a microfluidic chip.
Nonetheless, researchers have succeeded to replicate the
function of an alveolo-capillary membrane that is the tiniest
functional unit in the lung. This organ is the most vital part
when it comes to testing of new medicines, as it constitutes
the vital physical barrier between the body and the exterior
world. This device has the potential to become a valuable
tool for testing, absorption of aerosolized therapeutics,
effects of environmental toxins, and the safety and efficacy
of new drugs.
Heart on Chip
Speaking of serious health problems, heart disease certainly
tops the list. The number of deaths due to heart failure is
escalating day by day. Hearts-on-chips were developed,
specifically because of the substantial differences between
animal and human heart cells. Using this technology
scientists aim to study heart diseases and cardio-toxicity of
chemical treatments. In comparison with regular cell
culture, microfluidic chips allow collecting more relevant
data. The chip comprises of several wells, each with
separate tissues and integrated sensors, permitting experts to
study various engineered cardiac tissues at once. The chips
have the potential to become the best tool to study new
treatments against heart disease.
32 / September 2018/

35. Brain on Chip
Brain on chip research has helped to replicate a small part of
the brain, ‘the blood-brain barrier’, on chip. This barrier
has a crucial function: of protecting the brain from all the
pathogens in the blood and only lets through the nutrients
the brain needs. On the other hand, this barrier can be
problematic for some drug treatments, because it bars
selected active sites from accessing the brain such as the
medication against Parkinson’s disease. These microfluidic
chips permit experts to test the flow of a physiological fluid
on the epithelium; this mimics the blood flow and allows the
brain cells proper differentiation and maturation. In spite of
the fact that research in the field of blood-brain barrier
microfluidic chips is only starting out, several models
already exist.
Gut on Chip
Another organ here is the gut on a chip. The gut is a crucial
organ when it comes to absorption of medicine, and this
breakthrough technology would help us comprehend these
issues better; and fast forward research. Scientists have
developed a two-layer gut on chip system, similar to the
lung on chip discussed above. This technology, much like
the lung on chip, has proved to be very important, since it
has permitted to re-create the mechanical tension,
simulating peristaltic movement. During a particular study
using this technology, the researcher used stem cells from a
patient, who was suffering from digestive disorders, and
developed with a gut on chip tool. Using this, experts were
able to study the responses of the certain types of food and
new treatments. This illustration comes to show what
personalized medicine could look like, using organs on
chips.
Organs-On-Chips
/ September 2018 / 33

36. Multi-Organs on Chips
In the near future if developing organs on chips proved useful for testing certain treatments, in order to absolutely
replace animal testing or to simplify personalized medicine, it is essential to link these organs together. While
developing a new treatment strategy or drug it is vital to check the effect of these on the entire body as a whole. This is
where multi-organ on chips can help out. Most multi-organs methods have also permitted scientists to study absorption
and metabolism. Multi-organs on chips have allowed experts to carryout tests on previously existing medicine,
meanwhile also allowing the progress of anti-cancer research.
Promising Applications of theTechnology
Organs on chips can prove to be cheap and widely reproducible could be decisive. They could permit testing at a very
low cost, minus years of waiting periods. They will also cut down on the present ethical concerns, which come with
animal testing. This technology will provide increased access to personalized medicine. Organ on chips will help fight
the battle against cancer. Creating tumors on chips, would allow us to directly test the treatments on tumors. It will also
allow us to determine the side effects of certain treatments in advance. However, many challenges need to be addressed
in order to completely replace animal testing in the development of new medicine.
Organs-On-Chips
34 / September 2018/

38. Trexo
Robotics:
Delivering Futuristic &Innovative
Pediatric Wearable Robotic Devices
ver the years, various
solutions have come up to aid
Othe differentially abled; but
few were focused specifically for
children with disabilities. Today,
children with mobility impairments
spend a lot of time sitting, which has
been shown to lead to negative health
outcomes in the long-term. Without the
ability to walk, many children have a
hard time getting adequate exercise
and staying active.
The story of Trexo Robotics began in
2011 when its CEO Manmeet learned
that his nephew Praneit had cerebral
palsy and would not be able to walk.
With a desire to help his nephew,
Manmeet and his friend Rahul, CTO,
decided to take the matters into their
own hands. They both studied robotics
at the University of Waterloo, so
building a robot to help Praneit made a
lot of sense. Thus Trexo Robotics was
born in 2016.
Trexo Robotics designs and builds
pediatric wearable robotic devices to
help children with mobility
impairments experience walking. Its’
product, Trexo Plus, is the only fully
mobile robotic gait training platform
that is commercially available for
children. Trexo’s vision is to make this
technology available for home use so
that every child is able to walk
regularly. Through this vision, they are
looking to redefine mobility solutions
for people of all ages and abilities, by
building affordable and effective
products that empower individuals to
move and live a healthy life.
Fundamentally, the company is driven
by the belief that people should have
access to empowering technologies.
The Accomplished &Innovative
Leaders of Trexo
Trexo Robotics was founded in 2016,
by Manmeet Maggu (CEO) and
Rahul Udasi (CTO) as partners. They
began experimenting with various
robotics designs until the revolutionary
Trexo device came to life. Today, the
Trexo Plus is being prototyped and is
set to be piloted in an upcoming trial
with the Cincinnati Children's
Hospital. Praneit’s story has shaped the
company’s values and mission to
strongly focus on the children’s
experience and to learn from its end
users, including children, parents, and
physiotherapists in order to build
enjoyable and affordable products.
Feather in the Cap of Trexo
Together, the Trexo team has
experience bringing over 200 products
to market, taking these products from
ideas to mass production. These and
the founder’s experiences have rooted
Trexo’s culture in continuous
innovation. Manmeet strongly believes
that robotics has the potential for the
Manmeet Maggu
CEO &Co-founder
Rahul Udasi CT O
&Co-Founder
We want to reach the
point when every family
that has achild with a
disability, will have
access to and use the
Trexo device, giving
children more options
and independence
“
“
36 / September 2018/

39. betterment of society. Rahul, on the
other hand, is an enthusiast of
innovative robotics and is driven by his
curiosity.
Technologically, the company is at the
frontier of robotic design. The Trexo
team frequently tests its prototypes
with various children who could
benefit from this technology and learns
from their experiences. Recently,
following its participation in the
Canadian Technology Accelerator
Boston program, Trexo Robotics, won
a MIT Enterprise Forum Startup
Spotlight Award for theirlife-changing
innovation.
Trexo Plus: Strengthening the
Differentially Abled
Trexo Plus is the only fully mobile
robotic device designed specifically for
children to walk independently. Its
unique design allows it to convert a
passive walker into a fully powered
robotic device that can be used
anywhere. While starting as a physical
therapy device, Trexo’s goal is tomake
this device accessible to children and
their families at home so that they can
experience walking outside of a clinic.
The designs are made with a child’s
comfort and needs in mind, and
children with various conditions are
frequently invited to Trexo’s office to
try out the device and provide valuable
feedback. Ultimately, Trexo’s goal is to
create a device that physical therapists
trust, parents can afford and children
love. There are currently no such
devices available that can be used at
home by children. This device may be
used by children with conditions
including cerebral palsy, muscular
dystrophy, traumatic brain injury, spina
bifida, spinal cord injury and other
conditions which lead to mobility
impairments.
They strongly believe that leveraging
novel technologies can have a strong
impact on the care of people with
disabilities, as well as healthcare
overall. For instance, 3D-printing has
also allowed Trexo to test parts and
identify potential sources of issues
quickly, ensuring that when its device
hits the market, it is of high quality.
This type of rapid testing has also been
essential in keeping the company
sustainable and moving quickly. In the
future, Trexo is considering integrating
machine learning to improve the gait
training of each child as progress is
made, ensuring that the child continues
to benefit from the use of the device.
Present & Future of Trexo &
Medical Devices
The sad truth is that there isn’t much
innovation happening in the
accessibility and mobility space. This
market is still frequently overlooked
because there are significant barriers to
entry. Trexo hopes that by showing
people that with the usage of advanced
technologies like robotics, one can help
people in improving their lives and
create a profitable business.
Positive changes are happening, and
care providers are appreciating the
value of innovative technologies to
improve the quality-of-life of their
patients. At the end of July 2018,Trexo
will be placing its first unit for clinical
testing at the Cincinnati Children’s
Hospital. Additionally, it plans on
deploying four more units before the
end of 2018 for further evaluation.
Trexo is currently preparing for FDA
submission as well.
/ September 2018 / 37

40. AI isStarting
toChange
Radiology,forReal
he AI transformation is remarkable for itsspeed.
For example in conference such as RSNA
T(Radiology Society in North America) and ISMRM
(International Society of Magnetic Resonance in Medicine),
AI applications was still a niche area before 2016, but is the
top-1 hottest topic right now. We have passed beyond the
point that people doubted the applicability and potentials of
AI in radiology. Machine Learning and Deep Learning
algorithms have demonstrated good performance that can
supplement and verify the imaging tasks for radiologists.
Although still in early stage, variable AI algorithms have
already started to be test in clinical environment. This year
2018 is also a landmark year for AI in radiology, since
several AI+radiology products have received FDA’s
nodding that they can practice in clinics for segmenting
heart from MRI, make classification from CT, evaluate lung
nodules, etc.
Beyond Classification - AI Improves EntireRadiology
Workflow
Particularly, when talking about AI for radiology, most
people think of an AI algorithm that can eventually
“replace” radiologists and conduct diagnosis. When people
talk about the possibility of “replacing” radiologist, it is
important to recognize the complexity of radiology.
Radiologists are imaging experts with more than 10+ years
of medical training, who render diagnosis and clinical
decision suggestion from interpreting medical images and
correlating their findings from images with other exams and
Abouttheauthor:
Dr. Enhao Gong is the founder of Subtle
Medical. Dr. Gong graduated with a
Ph.D. in Electrical Engineering from
Stanford University in 2018, with
research focus on applying Deep
Learning to improve medical imaging
reconstruction, analysis, and
quantification. He has been awarded
Forbes China 30-under-30 in 2018, and
serves in the committee of Machine
Learning Workshop of ISMRM. Subtle
Medical Inc., is an AI+Radiology startup
founded by Dr. Enhao Gong and
Professor Greg Zaharchuk from Stanford
University, it is the Winner of 2018
NVIDIA Inception Award and Minnie
Semi-finalist of Best RadiologyVendor.
Dr. EnhaoGong
Subtle Medical
38 / September 2018/

41. tests. Currently, most AI algorithms are often designed for simplified ImageNet-ish image classification tasks, to
separate images from different categories such as with or without abnormality. It is clear that there are still huge gaps
between predicting a classification label, which is well studied and achieved by AI algorithms, and rendering final
diagnosis, which is much more complicated and requires both images and non-image information.
Beyond image classification, however, AI actually has great potentials to improve entire imaging/radiology
workflow. AI algorithms and products can supplement existing radiology solutions, with more efficient and accurate
imaging acquisition, reconstruction, analysis, detection, diagnosis, and prognosis, which goes way beyond predicting
labels of normal and abnormal tissues.
Several research works, including the works we have done at Stanford; recently demonstrate that Deep Learning
can replace conventional iterative algorithms for more accurate medical imaging reconstruction from 10x faster
MRI scan or even 200x lower-dose PET scans. In addition, a lot clinical research works in neuroradiology; showed
AI algorithms can not only categorize current disease, but also predict how the disease will progress in the future.
From faster exams to accurate prognosis prediction, the entire radiology workflow can be improved using AI.
Different from other AI+radiology companies and startups focus on automating radiology diagnosis using AI, we at
Subtle Medical chose a different route to integrate AI into clinical radiology. We provide hospitals and imaging
centers software infrastructure for AI-empowered imaging workflow enabling at least 4x faster and safer MRI and
PET exams. We believe these AI tools will help hospitals and imaging centers to improve their productivity, quality
of the service and patient satisfaction.
No Workflow Disruption from Disruptive AI Technology
It is no doubt that AI is a disruptive technology that will reform the radiology practice and workflow. However, the
innovation in radiology practice, as well as in healthcare in general, should never disrupt clinicians’ operation. There
is a saying that if the change of workflow requires radiologists to move from their chairs, it is not going to works. AI
is supposed to free clinicians from repetitive tasks, not to add more tasks to them. Therefore it is fundamental for an
AI product to seamlessly integrate into the entire workflow. For example, at Subtle Medical, all the products are
designed in a way to (semi-) automatically function between scanners and PACS, staying almost silent and invisible
to technicians and radiologists.
In general, we believe the best radiology tool should simplify, accelerate, and prioritize tasks for radiologists, making
exams more accurate, efficient and personalized, and improve the productivity and satisfaction for both patients and
clinicians. AI products have potentials to achieve all of these requirements.
Super-human Capability of AI
Several research works show state-of-the-art AI algorithms, such as Deep Learning, have great potentials in tasks
human professionals are not good at as well. For example, in identifying diagnosis disease subtypes, similar to fine-
grained image classification of identifying two similar dog breeds in ImageNet challenge, AI algorithms can do
better than human and resolve inter-reader variability. In addition, for all the repetitive and quantitative
measurements in radiology, such as contouring, segmentations, measuring brain thickness, and recording tumor size
changes, AI algorithm can not only free clinician from these time-consuming mundane tasks but also get more
accurate results. In addition, quantitative biomarkers and quantitative parameter mapping is a new trend in medical
imaging as it offers better objective criteria for clinical decision, where Deep Learning is shown to improve for MRI.
Last but not least, new algorithms lead ways to correlate radiology with large scale genetic datasets, which is too
complicated that human can never be good at but AI. All of these new advances from AI can contribute to
personalized and precision medicine in future radiology.
/ September 2018 / 39
Transforming Radiology

42. Still a Long Way to Go
Although AI in radiology has achieved a lot progresses, there are still a long way to go until it is routinely used in
clinics. In 2016, Dr. Geoffrey Hilton mentioned “it is quite obvious that we should stop training radiologists”.
Later, several AI papers published on achieving “expert-level performance” in diagnosis add-up the concerns
that radiologists should be worried about losing jobs. However nowadays we know there are definitely some
hypes in “replacing” radiologists. As the developers of radiology AI, we also understand and appreciate more
that radiologists are doing much more than image categorizing. Most AI/Computer-Assisted-Diagnosis products
are still in their early stage for a closed-set of a few disease categories.
AI, for a foreseeable future, will not be generalized. No human is better than a small calculator for accurate
arithmetic, but that is all that the calculator can do. Given the long-tail effects and the lack of datasets for rare
disease, it is unlikely AI can do everything for radiologists. But, as put by Dr. Langlotz from Stanford,
“radiologists who use AI will replace radiologists who don’t.” AI in radiology, probably similar to AI in other
popular areas such as manufacturing and autonomous driving, will keep improve its capability to change the entire
industry. As quoted in a recent Forbes article on robotics: AI will replace tasks, not jobs.
40 / September 2018/

43. YOU DON’T JOINUS,
WE JOIN YOU
SM
Whatever you health goals are, we’ll help you getthere.
w w w. ae t n a . co m

44. Zenflo
w:Driving the Future of BPH Relief
with Innovative Solutions
Problem-solving has long been
at the center of
entrepreneurship. The right
solutions bring in the right idea and the
right idea executed with the right set of
skills, creates wonders. Today, the
speed at which the technology has been
developing is ineffable; and with it
there have been continuous innovations
in various sectors of countless
industries. The healthcare industry isn’t
aloof of this pattern. Yet the healthcare
sphere, even after the digital
revolution, has not seen the amount of
development that it should have. There
is a lot of scope to improve the health
and subsequently the lives of people.
All it takes is the will and expertise to
do so.
Zenflow is a company started out of
the Stanford Bio design Fellowship in
2014 after witnessing the distress of
many men who were frustrated with
their symptoms of BPH (enlarged
prostate), and unhappy with the
treatments available. Zenflow is
developing an office-based treatment
to relieve the symptoms of BPH. It
aims to develop a less invasive therapy
with long-lasting effectiveness that can
be delivered in the doctor’s office with
minimal patient discomfort. While its
clinical trials are still in progress, the
results so far look very promising.
Conquering Challenges since the
Very Start
After establishing Zenflow in 2014, the
main challenges were to build a device
that could solve the identified need, to
prove that the device worked, and to
secure funding for the company. The
founding team of Zenflow addressed
that the funding had to come first,
before the other challenges. Being
resourceful, they pursued all available
options, including investor funding,
grants, and business plan competitions.
One of the biggest early breaks for
Zenflow was being funded by Y
Combinator as a part of the winter
2015 batch. It turned out to be a great
experience. Zenflow leveraged this
program to build its first working
prototype, collect chronic animal data,
and raise a seed round. From there, a
team was hired and Zenflow started
making faster progress. It started a
first-in-human study in mid-2016 and
has collected some very promising
data. Now, with a team of 15 full-time
people, Zenflow is initiating large trials
to prepare for commercial launch.
Innovative Products and Services
Zenflow is developing the Spring
System, which involves a small Nitinol
implant deployed through a flexible
cystoscopic system under direct
Nick Damiano
Co-founder &CEO
We aim to improve
patient care by
providing auniquely
safe and effective
treatment for men
with BPH symptoms
“
“
42 / September 2018/

45. visualization. It designed the implant to
provide solution for long-term risk,
while avoiding adverse effects like
migration and encrustation, issues that
plague prostatic stents. The designed
device is uniquely made, so that it can
push back the prostate while being
deliverable through a small, flexible
catheter in a simple procedure that is
easy for any urologist to learn and
perform. Zenflow is focused on the
patients’ need above all; always
innovating to improve safety,
effectiveness, and patient experience.
Compassionate and Zealous Leaders
of Zenflow
Nick Damiano, Co-Founder & CEO,
is seasoned with his experience as an
engineer and an entrepreneur, in both
medical devices and digital health
industries. He founded Zenflow along
with Shreya Mehta, Co-Founder &
CTO. She has an experience as a R&D
engineer at large medical device
companies and has spent four years as
a lead reviewer at FDA. Both founders
spent a year in the Stanford Bio design
Innovation Fellowship. The founding
team’s medtech background has given
them the practical know-how they
needed to get their product to market.
Adding to it, their experience from
outside the industry and from the other
side of the regulatory table has brought
new perspectives to their work at
Zenflow. In particular, the team takes a
collaborative approach in its
interactions with regulatory bodies and
other medical device companies,
sometimes even competitors. With
improving patient care at the core of
their mission, Nick and Shreya are
making their way to achieving that
goal, as partners.
Staying Abreast withChanging
Trends
Zenflow makes it a point to stay on top
of changing conditions in the
therapeutic space and market; and
thrive to adapt quickly to a clinical
need or changing landscape. In
particular, its major strategy is keeping
the communication lines open with
customers – patients, providers, and
payers. Addressing the clinical needas
well as possible is Zenflow’s top
priority. In terms of technological
changes, Zenflow has adopted 3D
printing for prototyping. With a
passion for success, every day matters
to the team of Zenflow; and 3D
printing gives them an ability to cut
their iteration cycle time down to a
fraction of what it would have been
years ago. It has made Zenflow a
faster, leaner, and more innovative
company. In working towards their
goal, Zenflow has not been afraid to
question its assumptions and adapt if
changing conditions or new
information warrants doing so.
Plan for an Avant-Garde Future
As far as its long-term strategy is
concerned, Zenflow likes to play its
cards close to the vest. Its ultimate
mission is to provide the safest, most
effective, most worry-free treatment for
BPH symptoms to all the patients
suffering from the disease. Zenflow has
some interesting concepts in its works,
which may expand the patient
population under treatment and
produce even better clinical results. It
also has some ideas that could allow
Zenflow to branch out into other
urologic areas.
/ September 2018 / 43

46. At Horizon, we’re driven by a
clear purpose; to improve
Patients’ Lives.
w w w . h o r i z o n p h a r m a . c o m

47. Healthcare
www.usa.philips.com