GBI Research's report "Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market" looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices. The report provides comprehensive information on establishment registration, medical device listing, Premarket Notification (510k) or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies, Quality System (QS) regulation, labeling requirements, and Medical Device Reporting (MDR). https://www.reportscorner.com/reports/20857/Changing-Regulatory-and-Reimbursement-Scenario-for-Medical-Devices-in-the-US-Market/

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Reports Corner
Changing Regulatory and Reimbursement
Scenario for Medical Devices in the US Market

2. DescriptionDescription
Reports Cornerwww.reportscorner.com
GBI Research's report "Changing Regulatory and Reimbursement
Scenario for Medical Devices in the US Market" looks at the
regulatory landscape and reimbursement scenario in the US for
four medical device markets: cardiovascular devices,
neurostimulation devices, diagnostic imaging devices and
endoscopy devices. The report provides comprehensive
information on establishment registration, medical device listing,
Premarket Notification (510k) or Premarket Approval (PMA),
Investigational Device Exemption (IDE) for clinical studies, Quality
System (QS) regulation, labeling requirements, and Medical
Device Reporting (MDR).

3. Brief SummaryBrief Summary
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Changing Regulatory and Reimbursement Scenario for Medical
Devices in the US Market
Summary
GBI Research's report "Changing Regulatory and Reimbursement
Scenario for Medical Devices in the US Market" looks at the
regulatory landscape and reimbursement scenario in the US for
four medical device markets: cardiovascular devices,
neurostimulation devices, diagnostic imaging devices and
endoscopy devices. The report provides comprehensive
information on establishment registration, medical device listing,
Premarket Notification (510k) or Premarket Approval (PMA),
Investigational Device Exemption (IDE) for clinical studies, Quality
System (QS) regulation, labeling requirements, and Medical
Device Reporting (MDR).

4. Brief SummaryBrief Summary
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The report also reviews the reimbursement scenario in these
medical device markets. It is built using data and information
sourced from proprietary databases, primary and secondary
research and in-house analysis by GBI Research's team of
industry experts.
Scope
- The report analyzes the regulatory and reimbursement scenario
for medical devices in the US.
- Information on the regulatory landscape in the US:
establishment registration, medical device listing, Premarket
Notification (510k) or PMA, IDE for clinical studies, QS regulation,
labeling requirements, and MDR.
- Information on reimbursement coverage in the US for
cardiovascular devices, neurostimulation devices, diagnostic
imaging devices and endoscopy devices.

5. Brief SummaryBrief Summary
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- Annualized market revenue data, forecast to 2018, for the
transcatheter heart valves market, left ventricular assist devices
market and endoscopy devices market.
- Qualitative analysis of key trends in the US regulatory and
reimbursement landscape.
Reasons to buy
- Develop business strategies by understanding the
reimbursement trends in the US medical devices market.
- Design and enhance your product development, marketing, and
sales strategies.
- Develop market-entry and market expansion strategies.
- Identify, understand and capitalize on the next big thing in the
US medical devices market landscape.

6. Brief SummaryBrief Summary
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- Make more informed business decisions from the insightful and
in-depth analysis of the US medical devices market and the
factors shaping it.

7. Table of ContentsTable of Contents
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1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 7
3 Overview of the Healthcare Reform Bill 8
4 Regulatory Landscape in the US 13
4.1 Overview of Medical Device Regulation 13
4.1.1 Establishment Registration 15
4.1.2 Medical Device Listing 15
4.1.3 New Medical Device Approval Process 16
4.1.4 Quality System Regulation/Good Manufacturing Practices 21
4.1.5 Labeling 21
4.1.6 Medical Device Reporting 22
5 Changing Reimbursement Scenario in the Medical Device Market 24

8. Table of ContentsTable of Contents
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5.1 Cardiovascular Devices 24
5.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 24
5.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 26
5.1.3 Reimbursement Coverage for Percutaneous Transluminal Angioplasty 28
5.2 Neurostimulation Devices 30
5.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 30
5.3 Diagnostic Imaging Devices 32
5.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 32
5.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 33
5.3.3 Reimbursement Cuts for Diagnostic Imaging Services 33
5.4 Endoscopy Devices 34
5.4.1 Reimbursement Coverage for Capsule Endoscope Systems 34
6 Appendix 38
6.1 Definitions 38
6.1.1 Cardiovascular Devices 38

9. Table of ContentsTable of Contents
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6.1.2 Diagnostic Imaging 38
6.1.3 Neurostimulation Devices 38
6.1.4 Endoscopy Devices 38
6.2 Acronyms 38
6.3 Sources 39
6.4 Research Methodology 41
6.4.1 Secondary Research 41
6.4.2 Primary Research 41
6.4.3 Models 42
6.4.4 Forecasts 42
6.4.5 Expert Panels 42
6.5 Contact Us 42
6.6 Disclaimer 42

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For more information please visit our website
https://www.reportscorner.com/reports/20857/Changing-Regulatory-and-
Reimbursement-Scenario-for-Medical-Devices-in-the-US-Market/

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