Regulatory: Page 235

Calypso receives 510(k)
By AuntMinnie.com staff writers
Electromagnetic localization developer Calypso Medical Technologies has been granted 510(k) clearance by the U.S. Food and Drug Administration for its Calypso 4D localization system.
August 7, 2006
Cook to bring Zenith graft to Japan
By AuntMinnie.com staff writers
Interventional technology developer Cook has received approval to market its Zenith endovascular graft system in Japan.
August 6, 2006
Totoku gets FDA OK for mammo display
By AuntMinnie.com staff writers
Japanese monitor manufacturer Totoku Electric has received U.S. Food and Drug Administration 510(k) clearance for its ME551i2 monochrome digital mammography display.
August 1, 2006
HHS releases final 'safe harbors' rules for health IT
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) yesterday released final regulations expected to make it easier for physicians to adopt electronic health records (EHR) technology.
August 1, 2006
Fuji adds to Synapse, DryPix
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received Food and Drug Administration 510(k) clearance for Obliquus, an integrated 3D software package for its Synapse PACS network.
July 31, 2006
Schering, Berlex expand Ultravist recall
By AuntMinnie.com staff writers
Schering and U.S. affiliate Berlex are voluntarily recalling all lots of its Ultravist Injection 370 mgI/mL x-ray contrast agent as part of a worldwide recall.
July 30, 2006
FDA extends Epix's Vasovist appeal
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has extended its review of Epix Pharmaceuticals' formal appeal for approval of the Cambridge, MA-based company's Vasovist blood-pool imaging agent.
July 30, 2006
IMS gets Canadian clearance for Giotto
By AuntMinnie.com staff writers
Italian x-ray and mammography systems developer Internazionale Medico Scientifica (IMS) has received clearance to market its Giotto Image MR-CA mammography unit in Canada.
July 26, 2006
Cook gets FDA OK on central venous catheter
By AuntMinnie.com staff writers
Interventional technology firm Cook reported that the U.S. Food and Drug Administration has cleared the latest iteration of the developer's Spectrum catheter.
July 24, 2006
NAS nets FDA nod
By AuntMinnie.com staff writers
Radiation therapy firm North American Scientific (NAS) said that its Nomos radiation oncology division has received U.S. Food and Drug Administration 510(k) clearance for its nomosStat serial tomotherapy automated treatment offering.
July 24, 2006
SmartPill gets FDA clearance
By AuntMinnie.com staff writers
SmartPill of Buffalo, NY, reported that its SmartPill GI monitoring system has received 510(k) clearance from the U.S. Food and Drug Administration.
July 19, 2006
Hologic receives EUREF approval
By AuntMinnie.com staff writers
Hologic has received Type Approval from the European Reference Organization for Quality Assured Breast Screening and Diagnostic Services (EUREF) for its Selenia digital mammography and SecurView systems.
July 19, 2006
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