Regulatory: Page 228

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
CMS rescinds IDTF rule changes
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) has backed down on a controversial proposal that would have implemented stringent new requirements for independent diagnostic testing facilities (IDTFs).
February 18, 2007
Medicsight lands Canadian licenses
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Medicsight has received medical device licenses from the Therapeutic Products Directorate (TPD) of Health Canada.
February 13, 2007
Rcadia receives FDA OK
By AuntMinnie.com staff writers
Computer-aided detection (CAD) software developer Rcadia Medical Imaging of Haifa, Israel, said it has received U.S. Food and Drug Administration clearance to market its COR Analyzer I application.
February 13, 2007
New CMS rules put the brakes on IDTFs
By Jonathan S. Batchelor
In a sweeping bid to cut Medicare fraud, the U.S. Centers for Medicare and Medicaid Services (CMS) has issued new rules scheduled to go into effect February 26 that raise the bar for sites applying to be designated as an independent diagnostic testing facility (IDTF). The new compliance standards, issued late last month as a change request, could dramatically change how IDTFs conduct their operations.
February 12, 2007
ART lands CE Mark
By AuntMinnie.com staff writers
Canadian optical molecular imaging developer ART Advanced Research Technologies has received the European CE Mark for its SoftScan optical breast imaging device.
February 7, 2007
DraxImage to bring generic sestamibi to market
By AuntMinnie.com staff writers
Canadian radiopharmaceutical firm DraxImage has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration for its generic kit for the preparation of technetium-99m (Tc-99m) sestamibi.
February 1, 2007
EOS begins clinical trial
By AuntMinnie.com staff writers
Medical device firm Electro-Optical Sciences (EOS) has begun a clinical trial for its MelaFind skin imaging device.
January 31, 2007
Previous Page
Page 228 of 302
Next Page