FDA: Page 14

FDA changes PMA advisory panel process
By AuntMinnie.com staff writers
In hopes of improving discussion and information flow, the U.S. Food and Drug Administration is changing the way its medical device advisory committees review and discuss data and information during public hearings on medical devices under review for premarket approval (PMA).
April 26, 2010
What's next for healthcare? And, FDA nixes handheld imaging app
By Brian Casey
March 22, 2010
FDA action may rain on iPhone's medical imaging parade
By Erik L. Ridley
Interest is booming in the use of mobile devices such as Apple's iPhone for image viewing applications. But that excitement may be dampened somewhat with a recent U.S. Food and Drug Administration decision to classify an iPhone image viewing application as a class III device requiring premarket approval.
March 22, 2010
FDA meeting to review 510(k) device process
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has scheduled a meeting in February to review its 510(k) premarket notification process for reviewing and clearing medical devices.
January 21, 2010
FDA takes its time with new FFDM rules; meeting to address MRI contrast
By Brian Casey
November 23, 2009
FDA issues draft guidance on CAD
By Erik L. Ridley
In what may be both good and bad news for the computer-aided detection (CAD) software industry, the U.S. Food and Drug Administration has released its long-awaited draft guidance for CAD technology.
October 21, 2009
Is breast screening oversold? And, GE to buy ONI; FDA issues CAD rules
By Brian Casey
October 21, 2009
FDA hangs fire on FFDM rules; VC for flat polyps
By Brian Casey
October 12, 2009
Mammography market awaits new FDA rules on FFDM regulation
By Kate Madden Yee
In 2006, the U.S. Food and Drug Administration said it wanted to make it easier for full-field digital mammography (FFDM) systems to get to market by relaxing the approval process. Three years later, the mammography industry is still waiting, a delay that some experts believe is contributing to higher prices for FFDM technology and limited access to new innovations.
October 12, 2009
Boston Scientific submits Taxus PMA data
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has submitted to the U.S. Food and Drug Administration the final modules of its premarket approval (PMA) applications for its Taxus Liberté Atom paclitaxel-eluting coronary stent system and its Taxus Liberté Long paclitaxel-eluting coronary stent system.
February 4, 2009
Neusoft Positron files 510(k) for Attrius
By AuntMinnie.com staff writers
Positron joint venture Neusoft Positron Medical Systems in Shenyang, China, has submitted a 510(k) application to the U.S. Food and Drug Administration for its Attrius cardiac PET scanner product line.
January 28, 2009
NY Times story focuses on CAD approval
By AuntMinnie.com staff writers
Developers of computer-aided detection (CAD) software are frustrated with the slow pace of new product regulatory approvals at the U.S. Food and Drug Administration (FDA). But according to a report published this week in the New York Times, agency scientists are using a recent CAD approval as an example that the FDA's approval process is too hasty.
January 14, 2009
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