FDA: Page 10

Siemens submits PMA for breast tomosynthesis
By AuntMinnie.com staff writers
Siemens Healthcare has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration for its Mammomat Inspiration mammography system with a digital breast tomosynthesis option.
June 25, 2014
RaySearch gets 510(k) clearance for pencil-beam option
By AuntMinnie.com staff writers
RaySearch has received 510(k) clearance for a pencil-beam scanning option for its RayStation 4.0 treatment planning system for proton therapy.
May 22, 2014
Redberg editorial calls for tighter device approvals
By AuntMinnie.com staff writers
Dr. Rita Redberg has co-authored a new editorial charging that the U.S. Food and Drug Administration should require new clinical trials for changes made to high-risk devices that have already been approved.
March 24, 2014
VuCOMP gets PMA for new CAD version
By AuntMinnie.com staff writers
VuCOMP has received U.S. Food and Drug Administration premarket approval (PMA) of version 3 of its M-Vu CAD software for digital mammography.
February 3, 2014
FDA: Breast transilluminators require PMA
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a final order requiring that a premarket approval (PMA) application be filed for a breast imaging technology called breast transillumination.
January 21, 2014
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
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