News
May 20, 2015
Marie Thibault FDA has tried to tackle the dilemma of off-label use of medical devices in children by giving industry guidance on extrapolating adult clinical...
May 19, 2015
Marie Thibault Over the last few years, cybersecurity has become a major topic in healthcare. While medical device companies have been warned repeatedly about...
May 18, 2015
Marie Thibault The long shelf life and uncommon business model of orthopedic implants is presenting a hitch in implementing FDA's Unique Device Identification...
May 14, 2015
Marie Thibault   The House of Representatives Energy and Commerce Subcommittee on Health is charging ahead on the proposed 21st Century Cures legislation...
May 13, 2015
Marie Thibault   FDA is showing that it takes patient input and preferences seriously, by giving the medical device industry new draft guidance on the...
May 12, 2015
Marie Thibault A bill recently introduced in the Senate calls for CMS to cover disposable medical technologies used at home as part of Medicare's durable...
May 11, 2015
Marie Thibault CDRH should have no shortage of training opportunities for its medical device reviewers, as several medical device companies have offered to...
May 07, 2015
Marie Thibault   FDA has thrown out 47 of its draft guidance documents, terming them outdated due to "new information, scientific developments, and...
May 05, 2015
Marie Thibault The Lavare algorithm is included in HeartWare's international HVADs, but not in domestic devices. HeartWare, one of two major makers of left...
May 05, 2015
Marie Thibault John Abele, co-founder of Boston Scientific, has held many titles throughout his life—founder, entrepreneur, philanthropist, and chairman...