Regulatory: Page 23

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Pharmaceutical company RepliGen Europe has withdrawn its application to the European Medicines Agency for a centralized marketing authorization for SecreFlo.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
Boston Scientific nets CE Mark
By AuntMinnieEurope.com staff writers
Interventional technology developer Boston Scientific has received the CE Mark for use of its Precision Plus spinal cord stimulator system in patients who are being treated with the system and need head MRI exams.
August 28, 2012
GE gets CE Mark for Discovery IGS730 angio system
By AuntMinnieEurope.com staff writers
GE Healthcare has received CE Mark approval for its Discovery IGS730 interventional x-ray system.
August 27, 2012
Neusoft nets ISO, CE Mark for Attrius
By AuntMinnieEurope.com staff writers
Neusoft Positron Medical Systems has received International Organization for Standardization (ISO) certification and CE Mark approval for its Attrius PET systems.
August 20, 2012
BSI publishes new device labeling standard
By AuntMinnieEurope.com staff writers
The British Standards Institution (BSI) has released a new international standard aimed at promoting global consistency in the labeling of medical devices.
July 24, 2012
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