Regulatory: Page 229

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
Varian gets FDA OK for RPM feature
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems of Palo Alto, CA, has received U.S. Food and Drug Administration 510(k) clearance for patient position monitoring capabilities for its RPM respiratory gating system.
January 29, 2007
ev3 gets FDA approval for Protege RX
By AuntMinnie.com staff writers
Interventional device firm ev3 of Plymouth, MN, has received U.S. Food and Drug Administration approval for its Protege RX carotid stent.
January 24, 2007
NovaRad gets mammo clearance
By AuntMinnie.com staff writers
PACS vendor NovaRad has received U.S. Food and Drug Administration clearance for reading and interpreting mammography studies on its NovaPACS product.
January 23, 2007
FlowCardia receives recanalization 510(k)
By AuntMinnie.com staff writers
Endovascular device developer FlowCardia said that it has received U.S. Food and Drug Administration 510(k) clearance for its Crosser 14 chronic total occlusion (CTO) recanalization system.
January 22, 2007
FDA OKs longer shelf life for Taxus
By AuntMinnie.com staff writers
Interventional device developer Boston Scientific said that the U.S. Food and Drug Administration has approved extending the shelf life of its Taxus Express² paclitaxel-eluting coronary stent system from 12 months to 18 months.
January 17, 2007
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