The Centers for Medicare & Medicaid Services reported it will offer coverage for transcatheter aortic valve replacement (TAVR) only under a coverage with evidence development framework, but despite the misgivings many in the device industry have about coverage with evidence development (CED), the only device maker with an approved device finds the decision flexible and promising with regard to future indications.

FDA and industry have agreed in principal to a new five-year user fee agreement for medical devices, and the $595 million agreed to is more than double the amount collected under the prior user fee agreement, which netted the agency less than $290 million. However, industry will get some bang for the buck thanks to FDA's agreement to measure device reviews by total elapsed time rather than just the number of days an application is on the agency's clock.

Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to examine the FDA whistleblower issue as a benchmark for drawn-out drama. As has been reported in Medical Device Daily, former FDA employees, including Robert C. Smith, MD, and Julian Nicholas, MD, were among the authors of letters to Congress and the Obama administration over alleged suppression of dissent over medical device approvals. Those letters came out in 2008 and...

The controversy over breast implants made with industrial-grade silicon has fanned out across the globe but it doesn't always seem as though the reaction and the facts jibe. There is a push in some nations to get women to have the implants made by Poly Implant Prothèse (PIP; La Seyne-sur-Mer, France), removed regardless of whether that woman has had a problem with her implants, but one question persists: Is the reaction proportional to the available data? The Jan. 12 news from Australia's Therapeutic Goods Administration is that...