FDA: Page 14

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
CTLM with mammo boosts breast cancer diagnosis
By AuntMinnie.com staff writers
CT laser mammography (CTLM) system developer Imaging Diagnostic Systems (IDSI) announced that a new study found that its CTLM system increased the accuracy of diagnosing malignant and benign breast lesions when used as an adjunct to mammography.
December 3, 2008
Medicsight submits 510(k) for ColonCAD
By AuntMinnie.com staff writers
Computer-aided detection developer Medicsight has filed a 510(k) application to the U.S Food and Drug Administration for its ColonCAD image analysis software.
November 19, 2008
CMS gets 510(k) for segmentation software
By AuntMinnie.com staff writers
Radiation therapy planning firm CMS has received U.S. Food and Drug Administration 510(k) clearance for its Atlas-Based Autosegmentation (ABAS) software.
August 21, 2008
FDA releases MRI implant guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has released a new guidance document covering the use of passive implants in MRI environments.
August 21, 2008
Meta Imaging nets 510(k) for breast system
By AuntMinnie.com staff writers
Meta Imaging Solutions has received 510(k) clearance from the U.S. Food and Drug Administration for its Chrysalis breast displacement system.
August 19, 2008
Medrad gets 510(k) for FDG infusion system
By AuntMinnie.com staff writers
Contrast injector technology firm Medrad has received 510(k) clearance from the U.S. Food and Drug Administration for Intego, a PET radiopharmaceutical infusion system.
June 17, 2008
FDA to ease rules on digital mammography systems
By Brian Casey
June 9, 2008
FDA proposes easier regulatory path for FFDM systems
By Cynthia E. Keen
The U.S. Food and Drug Administration is proposing changes to the way it regulates full-field digital mammography (FFDM) systems. The move should make it easier and less costly for mammography vendors to bring FFDM systems to market when the new rules are scheduled to go into effect in 2009.
June 9, 2008
Previous Page
Page 14 of 32
Next Page