RCReports CornerChanging Regulatory and ReimbursementScenario for Medical Devices in the US Market
DescriptionDescriptionReports Cornerwww.reportscorner.comGBI Researchs report "Changing Regulatory and ReimbursementScenar...
Brief SummaryBrief SummaryReports Cornerwww.reportscorner.comChanging Regulatory and Reimbursement Scenario for MedicalDev...
Brief SummaryBrief SummaryReports Cornerwww.reportscorner.comThe report also reviews the reimbursement scenario in theseme...
Brief SummaryBrief SummaryReports Cornerwww.reportscorner.com- Annualized market revenue data, forecast to 2018, for thetr...
Brief SummaryBrief SummaryReports Cornerwww.reportscorner.com- Make more informed business decisions from the insightful a...
Table of ContentsTable of ContentsReports Cornerwww.reportscorner.com1 Table of Contents1 Table of Contents 51.1 List of T...
Table of ContentsTable of ContentsReports Cornerwww.reportscorner.com5.1 Cardiovascular Devices 245.1.1 Reimbursement Cove...
Table of ContentsTable of ContentsReports Cornerwww.reportscorner.com6.1.2 Diagnostic Imaging 386.1.3 Neurostimulation Dev...
For more informationFor more informationReports Cornerwww.reportscorner.comFor more information please visit our websiteht...
Reports CornerThank YouThank Youwww.reportscorner.comRCContact us: contact@reportscorner.com
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Changing regulatory and reimbursement scenario for medical devices in the us market - Reports Corner

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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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Changing regulatory and reimbursement scenario for medical devices in the us market - Reports Corner

  1. 1. RCReports CornerChanging Regulatory and ReimbursementScenario for Medical Devices in the US Market
  2. 2. DescriptionDescriptionReports Cornerwww.reportscorner.comGBI Researchs report "Changing Regulatory and ReimbursementScenario for Medical Devices in the US Market" looks at theregulatory landscape and reimbursement scenario in the US forfour medical device markets: cardiovascular devices,neurostimulation devices, diagnostic imaging devices andendoscopy devices. The report provides comprehensiveinformation on establishment registration, medical device listing,Premarket Notification (510k) or Premarket Approval (PMA),Investigational Device Exemption (IDE) for clinical studies, QualitySystem (QS) regulation, labeling requirements, and MedicalDevice Reporting (MDR).
  3. 3. Brief SummaryBrief SummaryReports Cornerwww.reportscorner.comChanging Regulatory and Reimbursement Scenario for MedicalDevices in the US MarketSummaryGBI Researchs report "Changing Regulatory and ReimbursementScenario for Medical Devices in the US Market" looks at theregulatory landscape and reimbursement scenario in the US forfour medical device markets: cardiovascular devices,neurostimulation devices, diagnostic imaging devices andendoscopy devices. The report provides comprehensiveinformation on establishment registration, medical device listing,Premarket Notification (510k) or Premarket Approval (PMA),Investigational Device Exemption (IDE) for clinical studies, QualitySystem (QS) regulation, labeling requirements, and MedicalDevice Reporting (MDR).
  4. 4. Brief SummaryBrief SummaryReports Cornerwww.reportscorner.comThe report also reviews the reimbursement scenario in thesemedical device markets. It is built using data and informationsourced from proprietary databases, primary and secondaryresearch and in-house analysis by GBI Researchs team ofindustry experts.Scope- The report analyzes the regulatory and reimbursement scenariofor medical devices in the US.- Information on the regulatory landscape in the US:establishment registration, medical device listing, PremarketNotification (510k) or PMA, IDE for clinical studies, QS regulation,labeling requirements, and MDR.- Information on reimbursement coverage in the US forcardiovascular devices, neurostimulation devices, diagnosticimaging devices and endoscopy devices.
  5. 5. Brief SummaryBrief SummaryReports Cornerwww.reportscorner.com- Annualized market revenue data, forecast to 2018, for thetranscatheter heart valves market, left ventricular assist devicesmarket and endoscopy devices market.- Qualitative analysis of key trends in the US regulatory andreimbursement landscape.Reasons to buy- Develop business strategies by understanding thereimbursement trends in the US medical devices market.- Design and enhance your product development, marketing, andsales strategies.- Develop market-entry and market expansion strategies.- Identify, understand and capitalize on the next big thing in theUS medical devices market landscape.
  6. 6. Brief SummaryBrief SummaryReports Cornerwww.reportscorner.com- Make more informed business decisions from the insightful andin-depth analysis of the US medical devices market and thefactors shaping it.
  7. 7. Table of ContentsTable of ContentsReports Cornerwww.reportscorner.com1 Table of Contents1 Table of Contents 51.1 List of Tables 61.2 List of Figures 62 Introduction 73 Overview of the Healthcare Reform Bill 84 Regulatory Landscape in the US 134.1 Overview of Medical Device Regulation 134.1.1 Establishment Registration 154.1.2 Medical Device Listing 154.1.3 New Medical Device Approval Process 164.1.4 Quality System Regulation/Good Manufacturing Practices 214.1.5 Labeling 214.1.6 Medical Device Reporting 225 Changing Reimbursement Scenario in the Medical Device Market 24
  8. 8. Table of ContentsTable of ContentsReports Cornerwww.reportscorner.com5.1 Cardiovascular Devices 245.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 245.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 265.1.3 Reimbursement Coverage for Percutaneous Transluminal Angioplasty 285.2 Neurostimulation Devices 305.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 305.3 Diagnostic Imaging Devices 325.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 325.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 335.3.3 Reimbursement Cuts for Diagnostic Imaging Services 335.4 Endoscopy Devices 345.4.1 Reimbursement Coverage for Capsule Endoscope Systems 346 Appendix 386.1 Definitions 386.1.1 Cardiovascular Devices 38
  9. 9. Table of ContentsTable of ContentsReports Cornerwww.reportscorner.com6.1.2 Diagnostic Imaging 386.1.3 Neurostimulation Devices 386.1.4 Endoscopy Devices 386.2 Acronyms 386.3 Sources 396.4 Research Methodology 416.4.1 Secondary Research 416.4.2 Primary Research 416.4.3 Models 426.4.4 Forecasts 426.4.5 Expert Panels 426.5 Contact Us 426.6 Disclaimer 42
  10. 10. For more informationFor more informationReports Cornerwww.reportscorner.comFor more information please visit our websitehttps://www.reportscorner.com/reports/20857/Changing-Regulatory-and-Reimbursement-Scenario-for-Medical-Devices-in-the-US-Market/
  11. 11. Reports CornerThank YouThank Youwww.reportscorner.comRCContact us: contact@reportscorner.com

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