FDA: Page 9

Parascript lands PMA for CAD software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Parascript has received U.S. Food and Drug Administration premarket approval (PMA) for version 6.1 of its AccuDetect software.
September 4, 2013
Given gets PillCam 510(k) clearance
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for a new version of its camera-pill technology.
August 19, 2013
GE takes aim at breast tomosynthesis market
By Kate Madden Yee
GE Healthcare has long been one of the top two mammography firms, but the company until now hasn't had an offering in the cutting-edge breast tomosynthesis segment. That is changing, however: The firm has begun shipping its SenoClaire tomosynthesis system in Europe and has put the final touches on a regulatory application in the U.S.
August 4, 2013
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GE wraps up breast tomosynthesis PMA
By AuntMinnie.com staff writers
GE Healthcare has sent the final module of a premarket approval (PMA) application to the U.S. Food and Drug Administration for its GE Breast Tomosynthesis option.
July 29, 2013
Syntermed gets 510(k) for nuclear cardiac software
By AuntMinnie.com staff writers
Imaging software developer Syntermed has been awarded 510(k) clearance from the U.S. Food and Drug Administration for its Emory Cardiac Toolbox version 4.0 nuclear cardiac software.
May 19, 2013
VuCOMP secures PMA for digital mammography CAD
By Kate Madden Yee
Some things are worth the wait, believes computer-aided detection (CAD) developer VuCOMP about its newly approved CAD. The company has received premarket approval (PMA) notification for its M-Vu CAD software for digital mammography.
October 17, 2012
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U-Systems lands final clearance for somo.v for dense breasts
By Erik L. Ridley
Automated breast ultrasound technology developer U-Systems has become the first vendor to receive U.S. Food and Drug Administration clearance to market a device specifically for use in screening women with dense breasts.
September 17, 2012
FDA to review Hologic breast tomo extension
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is set to review an application by women's imaging vendor Hologic for an expansion of the clinical indications for its Selenia Dimensions 3D digital breast tomosynthesis mammography system.
August 23, 2012
FDA releases final guidance documents on CAD
By Erik L. Ridley
Nearly three years after the U.S. Food and Drug Administration published draft guidance on how it plans to regulate computer-assisted detection (CAD) technology, the agency has released the final versions.
July 8, 2012
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Hansen nets FDA 510(k) clearance
By AuntMinnie.com staff writers
Robotic technology developer Hansen Medical has received 510(k) clearance from the U.S. Food and Drug Administration for its Magellan robotic system for use in peripheral vascular interventions.
June 7, 2012
U-Systems receives FDA PMA letter for ABUS
By AuntMinnie.com staff writers
Automated breast ultrasound (ABUS) developer U-Systems has received a premarket approval (PMA) letter from the U.S. Food and Drug Administration for its somo.v ABUS system.
May 13, 2012
Novian Health begins breast cancer trial
By AuntMinnie.com staff writers
Novian Health has begun a multicenter clinical trial on the use of its Novilase interstitial laser therapy (ILT) for the destruction of malignant breast tumors, the company said.
April 11, 2012
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