FDA: Page 6

Mevion submits 510(k) to FDA for proton therapy system
By AuntMinnie.com staff writers
Mevion Medical Systems has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the Mevion S250i proton therapy system with the company's Hyperscan pencil-beam scanning technology.
September 17, 2017
Delphinus launches SoftVue clinical study
By AuntMinnie.com staff writers
Tomographic ultrasound technology developer Delphinus Medical Technologies announced that the first patient has been enrolled in a clinical study that will compare the performance of its SoftVue breast ultrasound device with mammography in dense breast tissue.
September 5, 2017
FDA responds to IsoRay's GammaTile 510(k)
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has issued a response to medical isotope developer IsoRay's pending 510(k) application for its GammaTile radiation therapy system.
July 5, 2017
Hologic nets FDA OK for tomo claim in dense breasts
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received approval from the U.S. Food and Drug Administration (FDA) to claim that its Genius 3D mammography tomosynthesis exam is superior for women with dense breasts.
June 6, 2017
SIIM: AI poised to enhance all aspects of radiology
By Erik L. Ridley
PITTSBURGH - Artificial intelligence (AI) will persistently and pervasively enhance all aspects of radiology, enabling precision medicine and potentially even finding disease before it becomes symptomatic, said Dr. Keith Dreyer, PhD, on Thursday at the Society for Imaging Informatics in Medicine (SIIM) annual meeting.
May 31, 2017
2017 06 01 10 11 07 128 Pittsburgh 400
NucleusHealth scores 510(k) for Nucleus.io software
By AuntMinnie.com staff writers
NucleusHealth has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nucleus.io cloud software for secure medical image management.
May 25, 2017
FDA hits firm with thermography warning letter
By AuntMinnie.com staff writers
A California provider of natural health products has been hit with a warning letter from the U.S. Food and Drug Administration (FDA) for a variety of alleged infractions, including using marketing claims for a breast thermography system that the FDA said have not been approved by the agency.
May 1, 2017
2016 09 02 09 36 05 93 Fda Logo V2 400
GE submits 510(k) for wide-bore MRI scanner
By AuntMinnie.com staff writers
GE Healthcare said its 3-tesla wide-bore MRI system, Signa Premier, is pending 510(k) clearance by the U.S. Food and Drug Administration.
April 27, 2017
2017 04 28 11 12 37 891 Signa Premier
FDA OK's iCAD tomosynthesis software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer iCAD said its PowerLook Tomo Detection software has received premarket approval from the U.S. Food and Drug Administration (FDA).
March 26, 2017
FDA OK's Fuji's breast tomo upgrade
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA said its digital breast tomosynthesis optional software upgrade has received premarket approval from the U.S. Food and Drug Administration (FDA).
January 23, 2017
Medicrea files 510(k) for 3D-printed spinal implant
By AuntMinnie.com staff writers
French implant developer Medicrea has filed a 510(k) submission for U.S. Food and Drug Administration clearance of its 3D-printed titanium patient-specific spinal implant.
January 8, 2017
QView lands FDA nod for ABUS CAD software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) software developer QView Medical said the U.S. Food and Drug Administration (FDA) has approved its premarket approval application for QVCAD, a CAD software package for automated breast ultrasound (ABUS) studies.
November 22, 2016
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