GAITHERSBURG, Maryland – There are times when changing a clinical study protocol midstream creates major headaches for device makers, but Biosense Webster (Diamond Bar, California) managed to sail through an advisory committee hearing last week with a unanimous vote for approvability despite the switch. (Medical Device Daily)

WASHINGTON – There is no shortage of healthcare reform proposals making the rounds on Capitol Hill, but the chairman of the Senate Finance Committee, Max Baucus (D-Montana) has some standing on the subject. The senator's Nov. 12 white paper did not mention cost containment in any conspicuous way, but Baucus released a legislative proposal shortly after the hearing that would expand the value-based purchasing (pay for performance) idea for hospitals all across the country. (Medical Device Daily)

WASHINGTON – The idea of parallel review of devices by FDA and the Centers for Medicare & Medicaid Services seems to have died on the vine, but a session held here Tuesday by the Food and Drug Law Institute (FDLI; Washington) suggests that observers of both agencies are divided on whether these two entities can realistically collaborate meaningfully on even less-contentious issues. (Medical Device Daily)

GAITHERSBURG, Maryland – The mere fact of an FDA advisory committee meeting is anything but conspicuous, but the fact that such a meeting addresses a 510(k) is somewhat unusual. (Medical Device Daily)