FDA: Page 13

Norwegian researcher launches DBT study
By AuntMinnie.com staff writers
A Norwegian researcher has launched a study that will compare the performance of digital breast tomosynthesis (DBT) to conventional digital mammography, according to a Norwegian hospital.
October 3, 2010
FDA panel gives nod to Hologic tomosynthesis PMA
September 23, 2010
FDA panel gives nod to Hologic tomosynthesis PMA
By AuntMinnie.com staff writers
An advisory panel of the U.S. Food and Drug Administration has unanimously approved a premarket approval (PMA) application from Hologic for a digital breast tomosynthesis (DBT) system. If the FDA signs off on the final PMA, Hologic will be the first vendor to sell a DBT system on the U.S. market.
September 23, 2010
Cook files PMA for renal stent
By AuntMinnie.com staff writers
Interventional technology firm Cook Medical has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for a balloon-expandable stent for renal artery disease.
September 23, 2010
FDA raises medical device user fees
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) plans to increase its medical device user fees by 8.5%, effective October 1.
September 13, 2010
FDA targets improvements to 510(k) process
By Erik L. Ridley
With an eye toward encouraging innovation, providing regulatory predictability, and ensuring patient safety, the U.S. Food and Drug Administration's Center for Devices and Radiological Health has issued two preliminary reports offering suggestions on how to improve the 510(k) program for medical devices.
August 3, 2010
Hologic secures panel date for tomo PMA
By AuntMinnie.com staff writers
Women's healthcare vendor Hologic has received a date for review of its Selenia Dimensions 3D digital mammography tomosynthesis system by the U.S. Food and Drug Administration.
July 26, 2010
AuntMinnie.com Business & Industry Insider
By Brian Casey
May 13, 2010
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
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