Regulatory: Page 23

DITTA supports initiative for global imaging
By AuntMinnieEurope.com staff writers
The Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) said it applauds the decision to post the Global Harmonization Task Force (GHTF) documents on the International Medical Device Regulators Forum (IMDRF) website to enable IMDRF to collaborate with industry to reach for consensus as to which task force documents should be recognized and maintained by IMDRF.
November 4, 2012
Acusphere seeks EU approval for cardio agent Imagify
By AuntMinnieEurope.com staff writers
Contrast developer Acusphere has filed a Marketing Authorization Application in the EU for its Imagify (Perflubutane Polymer Microspheres) cardiovascular disease detection agent.
October 25, 2012
3D imaging software from ORS gets CE Mark
By AuntMinnieEurope.com staff writers
Advanced visualization software developer Object Research Systems (ORS) announced that its ORS Visual 3D medical imaging software has received the CE Mark in Europe.
October 25, 2012
EU's CHMP offers positive opinion on Amyvid
By AuntMinnieEurope.com staff writers
Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Amyvid (florebetapir F-18) for injection as a PET radiotracer to detect beta-amyloid neuritic plaque in patients with cognitive impairment, according to Eli Lilly and its subsidiary Avid Radiopharmaceuticals.
October 18, 2012
Xograph's portable fluoroscopy unit wins CE Mark
By AuntMinnieEurope.com staff writers
Xograph Healthcare's OrthoScan Mobile DI portable fluoroscopy system has been awarded a CE Mark and is available for sale in the European Union, the company said.
October 10, 2012
Volcano gets FDA, CE Mark OK for IVUS catheter
By AuntMinnieEurope.com staff writers
Intravascular ultrasound developer Volcano announced that it has received both the CE Mark and 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new Visions PV.035 digital intravascular ultrasound imaging (IVUS) catheter.
October 8, 2012
Brand calls for broader EU health mandate
By AuntMinnieEurope.com staff writers
Speaking at last week's European Health Forum Gastein in Austria, the organization's president Dr. Helmut Brand, PhD, said the EU health mandate, for all the good it has accomplished so far, must be "redefined" in response to critical issues facing the union in 2012.
October 7, 2012
COCIR sets ecodesign targets for MRI
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) has published its Self-Regulatory Initiative (SRI) Status Report for 2011, which brings special focus on supporting green technology for MRI, the committee said.
October 2, 2012
ClearCanvas receives CE Mark for RIS/PACS
By AuntMinnieEurope.com staff writers
RIS/PACS company ClearCanvas has received CE Mark approval for its RIS/PACS software.
September 30, 2012
More details emerge on proposed EU device regulations
By AuntMinnieEurope.com staff writers
The European Commission has released its proposal for future regulation of medical devices, which replaces three current directives on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDD) with one regulation covering all medical devices and one regulation for IVDD.
September 27, 2012
COCIR welcomes new EU medical device regulation
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) has praised the European Commission for adopting a new medical device regulation that will now be considered by the European Parliament and European Union member states.
September 25, 2012
RepliGen withdraws application for MRI contrast agent
By AuntMinnieEurope.com staff writers
Pharmaceutical company RepliGen Europe has withdrawn its application to the European Medicines Agency for a centralized marketing authorization for SecreFlo.
September 13, 2012
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