FDA: Page 7

InSightec submits PMA for ExAblate Neuro
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its ExAblate Neuro device for treating essential tremor.
October 21, 2015
Seno wraps up study for Imagio optoacoustic breast system
By AuntMinnie.com staff writers
Optoacoustic breast imaging developer Seno Medical Instruments has finished the final phase of a pivotal study to evaluate its Imagio breast imaging system.
September 28, 2015
Acertara reaches 510(k) milestone
By AuntMinnie.com staff writers
Ultrasound acoustic measurement and testing firm Acertara Acoustic Laboratories recently reached the milestone of 900 successful submissions for 510(k) clearance.
September 22, 2015
Delphinus wins $39.5M in venture capital
By AuntMinnie.com staff writers
Tomographic ultrasound developer Delphinus Medical Technologies has received $39.5 million in venture capital funding.
September 9, 2015
Fuji files PMA module for digital tomo
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has submitted the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration for digital breast tomosynthesis.
July 15, 2015
VuCOMP submits PMA for breast tomo CAD
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer VuCOMP has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its CAD software for digital breast tomosynthesis.
April 22, 2015
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
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