FDA: Page 8

Koning gets OK to sell 3D breast CT scanner in U.S.
By AuntMinnie.com staff writers
Breast CT developer Koning has received U.S. Food and Drug Administration approval for its breast CT scanner, including a biopsy bracket add-on.
February 3, 2015
Siemens files 510(k) for CT lung cancer screening
By AuntMinnie.com staff writers
Siemens Healthcare has filed a 510(k) application with the U.S. Food and Drug Administration to market CT lung cancer screening on its entire line of CT scanners.
December 8, 2014
IRadimed submits 510(k) at FDA request
By AuntMinnie.com staff writers
MRI accessories company IRadimed has submitted a 510(k) application to the U.S Food and Drug Administration (FDA) for its MRidium 3860+ MRI IV infusion pump.
November 26, 2014
Seno touts reader study ruling out breast cancer
By AuntMinnie.com staff writers
Seno Medical Instruments released study results indicating that its Seno Imagio breast imaging system improves physicians' ability to rule out breast cancer, compared with traditional ultrasound alone.
November 2, 2014
MindwaysCT gets 510(k) for bone density software
By AuntMinnie.com staff writers
MindwaysCT has received 510(k) clearance from the U.S. Food and Drug Administration to market a new version of its software that acquires bone mineral density measurements from CT images.
September 30, 2014
Seno wraps up enrollment for Imagio trial
By AuntMinnie.com staff writers
Optoacoustic imaging developer Seno Medical Instruments said it has finished enrolling patients in a study of its Imagio breast imaging system.
September 23, 2014
GE files 510(k) for PET/MR system
By AuntMinnie.com staff writers
GE Healthcare has filed for 510(k) clearance of its new whole-body Signa PET/MR scanner with the U.S. Food and Drug Administration.
August 3, 2014
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
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