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

Published: May 2013
No. of Pages: 42
    ReportsandReports

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). 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.
  • 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.
  • Make more informed business decisions from the insightful and in-depth analysis of the US medical devices market and the factors shaping it.

Published By: GBI Research
Product Code: GBI Research1417


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