FDA: Page 12

FDA to launch new regulatory fast track for medical devices
By Kate Madden Yee
The U.S. Food and Drug Administration today announced a new priority review program for innovative medical devices. Products reviewed under the program could hit the market more quickly, with the FDA conducting reviews within 150 days -- nearly half the time it currently takes.
February 7, 2011
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FDA clears first app for image review on iPads, iPhones
By Erik L. Ridley
The U.S. Food and Drug Administration has issued 510(k) clearance of MIM Software's Mobile MIM application, the first mobile image viewing application to receive clearance for diagnostic use on Apple's iPhone and iPad devices.
February 3, 2011
FDA approves Carestream CR mammo software
By AuntMinnie.com staff writers
Carestream Health has received approval from the U.S. Food and Drug Administration for a premarket approval (PMA) supplement for advanced screens and image processing software for the company's computed radiography (CR) mammography system.
December 8, 2010
Imaging3 to resubmit 510(k) application
By AuntMinnie.com staff writers
3D imaging device developer Imaging3 announced it will resubmit an application to the U.S. Food and Drug Administration under the FDA's 510(k) process for its Dominion volumetric imaging scanner.
November 28, 2010
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
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