Gastroenterology
Volume 139, Issue 1 , Pages 32-35.e1 , July 2010

Bringing New Technologies to Market: Hurdles and Solutions

  • Joel V. Brill

      Affiliations

    • Corresponding Author InformationReprint requests Address requests for reprints to: Joel V. Brill, MD, AGAF, CHCQM, FASGE, FACG, Chief Medical Officer, Predictive Health, LLC, 6245 N. 24th Parkway, Suite 112, Phoenix AZ 85016. Phone: 602.418.8744; Fax: 480.452.0424

References 

  1. Foster RS Centers for Medicare and Medicaid Services, Office of the Actuary. Estimated Financial Impact of the “Patient Protection and Affordable Care Act”, as Amended. April 22, 2010;
  2. AdvaMed. The medical technology industry at a glance. Falls Church, VA: Author; September 7, 2004;
  3. U.S. Food and Drug Administration. What does it mean when FDA “clears” or “approves” a medical device. http://www.fda.gov/AboutFDA/Basics/ucm194460.htmAccessed May 9, 2010
  4. Morreim HE. The futility of medical necessity. Regulation. 2001;24:22–26
  5. 42 U.S.C. 1395y. Social Security Act, Exclusions from Coverage and Medicare as a Secondary Payer. Section 1862(a)(1)(A).

 Conflicts of Interest The author has made the following disclosures: Board of Directors: EndoChoice, Inc, Early Bird Alert, Inc; Executive Management Board and Chief Medical Officer: AGA Digestive Health Outcomes Registry. Advisor (in the past 24 months): Auxilium Pharmaceuticals, Centocor Ortho Biotech LLC, Eisai Pharmaceuticals, Novartis Corporation, SciDose LLC, The SmartPill Company, Boston Scientific, Given Imaging Ltd, Avantis Medical System Inc, Resonance Health Ltd, Xlumina, Vysera Biomedical Limited, Mauna Kea Technologies, EndoGastric Solutions, Exalenz Bioscience Ltd, Sandhill Scientific, Ethicon Endo-Surgery. Personal Possession of Shares: Early Bird Alert, Inc, Given Imaging Ltd. Options: EndoChoice, Inc, Early Bird Alert, Inc.

PII: S0016-5085(10)00731-6

doi: 10.1053/j.gastro.2010.05.003

Gastroenterology
Volume 139, Issue 1 , Pages 32-35.e1 , July 2010

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