Regulatory: Page 232

Mercury gets FDA OK
By AuntMinnie.com staff writers
Mercury Computer Systems said that the U.S. Food and Drug Administration granted the company clearance to market its Visage products.
November 16, 2006
eRad nets 510(k) for mammography viewing
By AuntMinnie.com staff writers
PACS firm eRad reported that it has received U.S. Food and Drug Administration 510(k) clearance for soft-copy viewing of digital mammography images.
November 16, 2006
EDDA gets 510(k) for liver software
By AuntMinnie.com staff writers
Computer-aided detection software developer EDDA Technology of Princeton Junction, NJ, has received clearance from the U.S. Food and Drug Administration to market its IQQA-Liver application.
November 15, 2006
FDA approves ACR to accredit Fuji CR mammo
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has approved the American College of Radiology to accredit the FCRm computed radiography mammography system from Fujifilm Medical Systems USA.
November 14, 2006
Viasys receives 510(k)
By AuntMinnie.com staff writers
Medical technology developer Viasys Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Sonora and Sonora/tek digital transcranial Doppler ultrasound systems.
November 14, 2006
NAS receives 510(k) for ClearPath
By AuntMinnie.com staff writers
Radiation therapy products developer North American Scientific (NAS) said it has received 510(k) clearance from the U.S Food and Drug Administration to market the high-dose-rate radiation treatment design of ClearPath, a multicatheter breast brachytherapy device.
November 13, 2006
Boston Scientific, GE integrate informatics apps
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said that the U.S. Food and Drug Administration approved the Natick, MA-based firm's Latitude 2.0 patient monitoring software with remote data integration capabilities.
November 8, 2006
BioSphere gets FDA nod for QuadraSphere
By AuntMinnie.com staff writers
Interventional device developer BioSphere Medical reported that the U.S. Food and Drug Administration has cleared the 510(k) application for the company's QuadraSphere microspheres.
November 8, 2006
Kodak submits final FDA data for approval of mammo CR
By AuntMinnie.com staff writers
Eastman Kodak Health Group said it has submitted the final module of a premarket approval (PMA) submission to the U.S. Food and Drug Administration for approval of its computed radiography (CR) system for mammography applications.
November 8, 2006
Planmed
By Kate Madden Yee
Planmed of Roselle, IL, plans to showcase Nuance, a work-in-progress full-field digital mammography unit with amorphous selenium detectors that come in large and small sizes.
November 8, 2006
Epix nets Canadian OK for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has received approval from Health Canada's Health Products and Food Branch (HPFB) for its Vasovist blood-pool MR angiography contrast agent.
November 5, 2006
Boston to bring Liberte to Japan
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific has received Japanese Ministry of Health, Labor and Welfare (MHLW) approval to market its Liberte bare-metal coronary stent system.
November 5, 2006
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