FDA: Page 12

IDSI submits 510(k) for CTLM
By AuntMinnie.com staff writers
Imaging Diagnostic Systems (IDSI) this week submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for its CT laser mammography (CTLM) breast imaging device.
November 22, 2010
Hologic's Selenia nets FDA letter
By AuntMinnie.com staff writers
Women's healthcare vendor Hologic has received an approvable letter from the U.S. Food and Drug Administration for the Selenia Dimensions 3D digital mammography tomosynthesis system.
November 22, 2010
FDA 510(k) process unpredictable and costly, study indicates
By Wayne Forrest
A survey of some 200 medical device companies by Stanford University in Stanford, CA, shows that many respondents view the current premarket clearance process by the U.S. Food and Drug Administration as unpredictable and plagued by disruptions and delays.
November 21, 2010
FDA's revision of FFDM rules may break market logjam
By James Brice
Breast imaging providers in the U.S. may soon witness a surge of new full-field digital mammography (FFDM) products on the market, thanks to the U.S. Food and Drug Administration's November 4 decision to ease its rules for approval of FFDM technology.
November 17, 2010
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
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