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Regulatory: Page 30
RaySearch gets FDA nod
By
AuntMinnieEurope.com staff writers
Swedish radiation therapy firm RaySearch has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RayStation treatment planning system.
March 16, 2010
FDA, Health Canada approve Polish moly
By
AuntMinnieEurope.com staff writers
The U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor in Poland as a site to irradiate highly enriched uranium targets for molybdenum-99 production, according to healthcare technology firm Covidien.
March 10, 2010
Rcadia receives CE Mark for COR Analyzer
By
AuntMinnieEurope.com staff writers
Computer-aided detection developer Rcadia Medical Imaging has received the European CE Mark for its COR Analyzer software.
March 7, 2010
New European regs spotlight need for clinical radiology audits
By
Rob Skelding
VIENNA - The term "audit" may strike fear into the hearts of even the finest organized radiology departments. But if performed well, clinical audits can be an effective way to support -- and even promote -- your radiology services, delegates heard Saturday at the European Congress of Radiology.
March 5, 2010
Threats to ultrahigh-field MRI in Europe
By
Denis Le Bihan
A new European directive designed to prevent workers from being exposed to high magnetic fields could potentially have a severe impact on MRI research, warns Denis Le Bihan, director of the NeuroSpin intense-field neuroimaging project at the CEA-Saclay Center in Gif-sur-Yvette, France.
October 8, 2009
Michelson gets nod for OCT scanner
By
AuntMinnieEurope.com staff writers
Michelson Diagnostics has won the CE Mark for clinical use of its VivoSight optical coherence tomography (OCT) scanner in Europe, in addition to nonclinical use worldwide.
September 17, 2009
Hansen nets FDA OK, shows new products
By
AuntMinnieEurope.com staff writers
Robotic technology developer Hansen Medical has received U.S. Food and Drug Administration clearance for its next-generation Sensei X robotic catheter system.
September 15, 2009
Ziosoft nets CE Mark
By
AuntMinnieEurope.com staff writers
Advanced visualization software developer Ziosoft has received the European CE Mark for its Ziostation 3D thin-client software package.
June 30, 2009
Pie software gets FDA nod
By
AuntMinnieEurope.com staff writers
Imaging firm Pie Medical Imaging has received U.S. Food and Drug Administration clearance for its CAAS MR Flow software.
May 26, 2009
IMRIS wins CE Mark for MR angiography suite
By
AuntMinnieEurope.com staff writers
Canadian intraoperative MRI technology developer IMRIS has received the CE Mark for its MR imaging and x-ray angiography suite.
April 30, 2009
Bracco revisits plans for U.S. launch of SonoVue
By
AuntMinnieEurope.com staff writers
VIENNA - Italian contrast firm Bracco Imaging is reviving plans to launch its SonoVue contrast agent in the U.S. The Milan firm plans to sponsor a multicenter clinical trial this year to collect data for a regulatory submission to the U.S. Food and Drug Administration.
March 7, 2009
Varian wins CE Mark for proton therapy system
By
AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received the European CE Mark for its proton therapy system.
February 19, 2009
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