The process of clearance and approval of medical devices has been all over the media radar screen, and the Journal of the American Medical Association (JAMA) has chimed in with an article alleging that device applications have been subjected to less scrutiny than drug applications. (Medical Device Daily)
The U.S. Senate has pushed through a healthcare reform bill – a mammoth 2,500-page chunk of legislation with bargains grand and petite for a number of stakeholders – by a party-line vote of 60-39. Despite the seeming momentousness of the occasion, one last hurdle remains: managing the merger of the Senate's legislative tome with the relatively house bill, which comes in at roughly 1,100 pages. (Medical Device Daily)
GAITHERSBURG, Maryland — The ear, nose and throat devices advisory committee met last week to take up the matter of the Esteem implant for hearing loss, made by Envoy Medical (St. Paul, Minnesota) and as is often the case of late with medical device advisory committees, the agency allowed the panel to take up a matter that is outside the panel's purview. (Medical Device Daily)