The FDA’s Circulatory Devices panel recommended expanded approval for Edwards Lifesciences‘ (NYSE:EW) Sapien heart valve to include a lower-risk group of patients, voting 11-0 in favor of approval with 1 panelist not voting.
Food & Drug Administration (FDA)
FDA’s Shuren: “The canary in the coal mine is actually singing these days”
The FDA has made important strides in improving its medical device review process, devices chief Dr. Jeffrey Shuren said this week.
Since beginning an audit of the agency’s med-tech review procedures nearly 2 years ago, fewer medical device market applications have been sent back to companies and average decision times are on the decline, Shuren told an audience at the Memphis Bioworks Assn. Monday.
AdvaMed CEO Ubl calls on Senate to repeal the device tax | MassDevice.com On Call
MASSDEVICE ON CALL — Following the U.S. House of Representatives’ sweeping repeal of the impending 2.3% medical device tax, lobbying efforts have turned to urging the Dem-led Senate to follow suit.
As a Senate bill repealing the medical device tax languishes without Democratic support, some have speculated that repeal efforts are dead in the water, but AdvaMed president & CEO Stephen Ubl took to the opinion pages to urge the nation’s upper house to spike the levy.
St. Jude shares sink on single Durata lead wire defect report
St. Jude Medical (NYSE:STJ) shares closed down 6% after a single incident of wire externalization in 1 of its next-generation Durata defibrillator leads – the same issue the launched the high-profile recall of the company’s Riata leads.
MassDevice.com +3 | The top 3 med-tech stories for June 12, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
FDA inaugurates annual patient network meeting
By: Richard M. Klein
FDA has a long history of working with patients and patient advocates, beginning with the AIDS crisis of the 1980s. Our interactions with patient groups have evolved since then, and the agency now works with patients representing a broad spectrum of diseases and conditions.
Internal FDA disputes may affect regulatory outcomes for medical devices
Internal disputes at the FDA’s Center for Devices & Radiological Health need better management in order to avoid disruptions to the medical device review process, according to the U.S. Dept. Of Health & Human Services’ Office of the Inspector General.
Although most of the disputes involved disagreements over fulfilling agency requirements, some may have come from lack of clarity and uncertainty about the submission process, according to the OIG.
CDRH process for resolving internal medical device review disagreements needs improving
By Stewart Eisenhart, Emergo Group
Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Services Department.
BSX’s Mahoney details outlook on up-and-coming businesses, including renal denervation and ICDs
Boston Scientific’s (NYSE:BSX) got a busy road ahead, with regulatory approvals and market launches in the works for products in some of its hottest business divisions.
FDA: Possible selection bias issues ‘confound’ Edwards’ Sapien study
UPDATED 6/11/2012 2:30 p.m. with comment from Edwards