Tag:
510(k) clearance
Latest Headlines
Latest Headlines
GAO: FDA device approval times drastically slower
Many in the medical device industry see the FDA approval process as only having gotten more cumbersome and slow. A new report from the Government Accountability Office adds more fuel to the fire.
FDA clears Cordis' Empira catheters
The FDA has cleared Cordis' EMPIRA and EMPIRA NC RX PTCA dilatation catheters for the treatment of coronary artery disease. The U.S. launch is expected early next year. "The EMPIRA Balloon Catheters
NEJM authors come out in support of IOM report
The IOM's report on reforming the 510(k) system is out, and many industry insiders are speaking against it. And despite the vociferous uproar, Drs. Gregory Curfman and Rita Redberg in the New England
IOM report fuels debate over device reviews
Dump the 510(k) process. At the end of the day, that was the Institute of Medicine's (IOM) advice to the FDA in its much-anticipated report Friday. The nonprofit group, tasked by the FDA to generate
IOM report on changes in med device approvals expected Friday
The medical device industry is gearing up for Friday, when the Institute of Medicine will recommend how the FDA could tweak its accelerated 510(k) approval process that takes into account both the
Between a Political Rock and Industry Hard Place: The FDA's 510(k) Initiative
Waiting for the changes to the 510(k) process has left many in the medical device industry nervous. It has been a long process, with politicians, industry and the FDA itself weighing in. And we
Hatch, FDA officials address MDMA
Washington, D.C. -- A bevy of medical device execs gathered in the nation's capital last week for the annual meeting of the Medical Device Manufacturers Association to hear hot topics affecting the
Shuren to appear before House panel this week
CDRH head Jeffrey Shuren will finally appear before the a U.S. House Oversight & Government Reform subcommittee to discuss the FDA and its medical device approval process. The panel had been
Survey: Device firms view FDA review process as unpredictable
Roughly two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first, delaying the availability of those products in the U.S., according to a
Spring-Set Health Solutions gets 510(k) clearance for diabetes treatment
Spring-Set Health Solutions, a unit of D. Medical Industries, has received 510(k) clearance to market its Spring universal infusion sets in the U.S. Through its subsidiaries, D. Medical is engaged in
