Smith & Nephew (FTSE:SN, NYSE:SNN) said it’s launching its Polarstem cementless hip stem in the United States for total hip replacement procedures.
Food & Drug Administration (FDA)
Medtronic lands U.S., E.U. wins for miniature cardiac monitor
FDA reviews adverse events, durability of Inspire Medical’s sleep apnea implant
Minnesota-based Inspire Medical Systems has a date with the FDA tomorrow, when the agency’s expert Anesthesiology & Respiratory Therapy Devices Panel will review data and make a recommendation on the Inspire II Upper Airway Stimulator.
Regulatory science supports FDA’s regulatory mission
By: Carolyn A. Wilson, Ph.D.
Admedus gains U.S. clearance for cardiovascular scaffold
Admedus won 510(k) clearance from the U.S. FDA for its CardioCel cardiovascular scaffold.
Perth, Australia and Minneapolis, Minn.-based Admedus is developing implantable regenerative technologies. CardioCel, the company’s 1st product, is a pure collagen, bio-compatible regenerative tissue scaffold.
Claret Medical lands FDA OK for U.S. trial of Sentinel cerebral protection device
Claret Medical is clear to launch a pivotal U.S. trial of its Sentinel cerebral protection system, having won FDA approval to evaluate the device in patients undergoing transcatheter aortic valve implantation.
The study is slated to begin in the 1st quarter of 2014 and will involve up to 15 clinical centers, Claret reported.
U.S. lawmakers seek regulatory exemptions for some mobile medical devices and apps
By Stewart Eisenhart, Emergo Group
Legislators in the US House of Representatives and Senate are considering bills that would exempt several types of software, mobile medical devices and apps from Food and Drug Administration oversight.
Dr. Tom Fogarty: My balloon catheter wouldn’t survive today’s FDA
Superstar medical device inventor and industry legend Dr. Thomas Fogarty may have ended up in a very different place had he come up under today’s FDA.
Report: FDA 510(k)s times up 50% since 2006 | MassDevice.com On Call
MASSDEVICE ON CALL — Review times have increased significantly for the FDA’s fast-track 510(k) pathway, taking an average of about 50% longer today than they took in 2006, according to an industry report.
An Emergo Group analysis found that 510(k) applications cleared in 2013 took about 166 days to go from initial submission to final decision, compared with only 110 days in 2006. Still, current review times are down from a peak of 176 days in 2011.
FDA sets a date to review XVIVO’s lung perfusion system
Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.
XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.
Skepticism for Apple’s medtech prospects | MassDevice.com On Call
MASSDEVICE ON CALL — The market is awash with rumors that Apple Inc. (NSDQ:AAPL) is planning on building some medtech into its smartphones, but not everyone’s ready to jump on the rumor wagon.