FDA: Page 13

Siemens gets PMA for FFDM unit
By AuntMinnie.com staff writers
Siemens Healthcare has received U.S. Food and Drug Administration premarket approval (PMA) for its Mammomat Inspiration full-field digital mammography (FFDM) system.
November 17, 2010
FDA approves Carestream CR FFDM system
By AuntMinnie.com staff writers
Carestream Health has received approval from the U.S. Food and Drug Administration for its high-resolution computed radiography (CR) full-field digital mammography (FFDM) system.
November 3, 2010
FDA eases rules on digital mammography devices
By Kate Madden Yee
The U.S. Food and Drug Administration has downgraded the classification of full-field digital mammography devices from high risk to medium risk, making it easier for companies to bring the technology to market, the agency announced.
November 3, 2010
Varian gets 510(k) for Acuros
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received U.S. Food and Drug Administration 510(k) clearance for its Acuros XB dose-calculation algorithm.
October 31, 2010
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
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