Regulatory: Page 236

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
CCHIT grants ambulatory EHR certification for 17 firms
By AuntMinnie.com staff writers
U.S. Department of Health and Human Services (HHS) Secretary Mike Leavitt announced today that the first ambulatory electronic health record (EHR) products have been certified by the Certification Commission for Healthcare Information Technology (CCHIT).
July 17, 2006
Matrox shipping RoHS boards
By AuntMinnie.com staff writers
Medical display controller board developer Matrox Graphics reported that four of its display controller board series are compliant with the European Parliament and the Council of the European Union directive on the restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment.
July 17, 2006
Merit nets CE Mark
By AuntMinnie.com staff writers
Disposable products provider Merit Medical Systems has received the CE Mark to market its Impress catheter in Europe.
July 16, 2006
Fuji CR mammo approval offers new option for breast imaging
By Kate Madden Yee
Fujifilm Medical Systems USA announced today that the FDA has given final approval to its premarket approval (PMA) application for a full-field digital mammography (FFDM) system based on computed radiography (CR) technology. The approval gives breast imaging facilities a new option for going digital that should prove to be more economical than FFDM systems currently on the market, according to this Technology Review article.
July 10, 2006
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Kyron gets Prism clearance
By AuntMinnie.com staff writers
MRI advanced visualization application developer Kyron Clinical Imaging has received U.S. Food and Drug Administration clearance to market its Prism Acquire and Prism Process brain imaging products in the U.S.
July 10, 2006
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