Regulatory: Page 247

RamSoft gets mammo clearance
By AuntMinnie.com staff writers
Canadian PACS vendor RamSoft has received Food and Drug Administration 510(k) clearance for use of its PowerServer 4.0 software suite in digital mammography applications.
October 5, 2005
Schering, Epix score European approval for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals and marketing partner Schering have received clearance to market Epix's Vasovist blood-pool contrast agent in the European Union.
October 4, 2005
GE cleared to launch Altitude
By AuntMinnie.com staff writers
GE Healthcare has received Food and Drug Administration clearance for OEC Altitude, a new fluoroscopic imaging system.
October 3, 2005
GE nets heart approval for Omniscan in Denmark
By AuntMinnie.com staff writers
GE Healthcare said that the Danish Medicines Agency has approved its Omniscan MR contrast agent for use in myocardial perfusion imaging and delayed enhancement for detecting coronary heart disease.
September 29, 2005
IDSI notches Italian order
By AuntMinnie.com staff writers
CT laser mammography (CTLM) developer Imaging Diagnostic Systems (IDSI) has sold its third CTLM system in Italy.
September 29, 2005
Toshiba nets FDA clearance
By AuntMinnie.com staff writers
Toshiba America Medical Systems of Tustin, CA, said it has received Food and Drug Administration clearance for its Aquilion LB (large bore) CT scanner.
September 28, 2005
New electronic healthcare claims standard published
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) has published a proposed rule adopting standards for electronic healthcare claims attachments.
September 25, 2005
FDA issues draft CGMP for PET radiopharmaceuticals
By AuntMinnie.com staff writers
The Food and Drug Administration has drafted a current good manufacturing practices (CGMP) regulation for the production of pharmaceuticals used in PET imaging, the agency reported.
September 25, 2005
Kodak gets nod for mammo CAD upgrades
By AuntMinnie.com staff writers
Eastman Kodak Health Group has received Food and Drug Administration clearance for enhancements to its computer-aided detection (CAD) system.
September 20, 2005
FDA approves Abbott carotid stent
By AuntMinnie.com staff writers
The Food and Drug Administration has approved a carotid stent from Abbott Laboratories that's designed to be a minimally invasive treatment for patients with carotid artery disease.
September 15, 2005
FDA posts guidance for mammo centers hit by Katrina
By AuntMinnie.com staff writers
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has issued guidelines on how to manage mammography programs in the wake of a natural disaster, such as Hurricane Katrina.
September 8, 2005
Boston Scientific gets Taxus CE Mark
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said it has received the European CE Mark for its Taxus Liberté paclitaxel-eluting stent system.
September 7, 2005
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