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)

GAITHERSBURG, Maryland – As some device makers tell it, enrolling patients into a randomized clinical trial (RCT) is like getting dancers on the dance floor, at least in one respect; it's tough to get someone to be the first. Unlike the accumulation of dancers on the dance floor, however, the arrival of the first enrollee in an RCT does not ensure a landslide of participation. (Medical Device Daily)

The Centers for Medicare & Medicaid Services has wrestled for some time with the issue of reimbursement for angioplasty and stenting of the carotid artery in patients who are not good candidates for carotid artery endarterectomy (CAE), and yesterday's announcement that the agency would essentially hold its ground was not well received. One physician who has been involved in the issue for some time called the decision "an open stinking wound," but other voices say CMS already has plans to yield on coverage for high-risk patients. (Medical Device Daily)