FDA: Page 9

C4 Imaging nets 510(k) clearance for MRI marker
By AuntMinnie.com staff writers
C4 Imaging has received U.S. Food and Drug Administration 510(k) clearance for its Sirius MRI marker.
December 8, 2013
CIVCO gets 510(k) for robotic system
By AuntMinnie.com staff writers
Ultrasound and radiotherapy products developer CIVCO Medical Solutions has received regulatory clearance for an integration of its Protura robotic patient positioning system.
October 7, 2013
GE touts ABUS study
By AuntMinnie.com staff writers
GE Healthcare is pointing to a recent study that showed that radiologists using automated breast ultrasound (ABUS) had high interreader agreement.
September 19, 2013
InSightec launches ExAblate trial
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has treated the first patient for essential tremor in a phase III clinical trial of its ExAblate Neuro system.
September 9, 2013
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
2013 08 01 14 43 18 660 Ge Seno Claire 200
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
2012 10 18 09 23 06 449 Vu Comp Mass Mark 70
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
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