Regulatory: Page 228

Health Canada issues gadolinium advisory
By AuntMinnie.com staff writers
The Canadian health regulatory agency Health Canada has issued a regulatory advisory to healthcare professionals in the country regarding the use of contrast agents containing gadolinium.
March 14, 2007
InSightec nets Canadian approval
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received approval from Health Canada for its ExAblate 2000 MR-guided focused ultrasound (MRgFUS) system.
March 11, 2007
European radiology mobilizes to stave off MRI safety rules
By Brian Casey
VIENNA - A number of European academic societies, including the European Society of Radiology (ESR), have formed a coalition to try to prevent the adoption of safety rules set to go into effect in 2008 that could severely limit the types of MRI studies that can be conducted in the European Union. Called the Alliance for MRI, the coalition was launched here today at the European Congress of Radiology (ECR).
March 8, 2007
Kodak nets Health Canada OK for CR mammo
By AuntMinnie.com staff writers
Eastman Kodak Health Group reported that it has received Health Canada approval for its DirectView CR mammography product.
March 5, 2007
InSightec nets FDA clearance for new software
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received U.S. Food and Drug Administration (FDA) clearance for a new software version for its ExAblate 2000 MR-guided focused ultrasound (MRgFUS) system.
March 4, 2007
Medtronic submits PMA for Talent Thoracic
By AuntMinnie.com staff writers
Interventional technology firm Medtronic has submitted the final module of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Talent Thoracic stent-graft system.
March 4, 2007
NeuroLogica gets Canadian nod
By AuntMinnie.com staff writers
Mobile CT developer NeuroLogica has received the Canadian Medical Device License for its CereTom mobile CT scanner.
March 4, 2007
FDA clears InSightec's ExAblate 2000 for GE 3T MRI
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received clearance from the U.S. Food and Drug Administration to use its ExAblate 2000 incisionless surgery system for uterine fibroids with 3-tesla MRI scanners from GE Healthcare of Chalfont St. Giles, U.K.
February 28, 2007
ACR releases new MR safety guidelines
By AuntMinnie.com staff writers
The American College of Radiology (ACR) has released updated MR safe practice guidelines. The 2007 version contains information on nephrogenic systemic fibrosis (NSF), a reaction to gadolinium that has been noted in patients with renal disease.
February 28, 2007
Epix files formal appeal for Vasovist
By AuntMinnie.com staff writers
MRI contrast developer Epix Pharmaceuticals has submitted a formal appeal to the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA), asking the CDER to approve its blood-pool imaging agent Vasovist (gadofosveset trisodium injection).
February 27, 2007
Regulatory carve-outs hope to spur HIT growth in U.S.
By Jonathan S. Batchelor
NEW ORLEANS - Exceptions to the Stark law and safe harbor provisions may provide the incentive to deliver healthcare information technology (HIT), such as electronic prescribing and electronic health record (EHR) systems, to small to mid-size physician groups in the U.S., according to a presentation at this week's Healthcare Information and Management Systems Society (HIMSS) conference.
February 27, 2007
Intelerad gets FDA nod, installs PACS down under
By AuntMinnie.com staff writers
Montreal-based PACS vendor Intelerad Medical Systems said that the U.S. Food and Drug Administration (FDA) has cleared its IntelePACS and InteleViewer Workstations for the interpretation of digital mammographic images.
February 26, 2007
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