Regulatory: Page 22

Lily gets EU approval for Amyvid PET radiotracer

By AuntMinnieEurope.com staff writers

Eli Lilly subsidiary Avid Radiopharmaceuticals has received marketing authorization from the European Commission for its Amyvid (florbetapir F-18) PET radiotracer.

January 15, 2013

GE files applications for F-18 flutemetamol

By AuntMinnieEurope.com staff writers

The U.S. Food and Drug Administration and the European Medicines Agency have accepted applications from GE Healthcare for review of its investigational F-18 flutemetamol PET amyloid imaging agent.

January 7, 2013

Navidea submits Lymphoseek application to EMA

By AuntMinnieEurope.com staff writers

Radiopharmaceutical developer Navidea Biopharmaceuticals has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its investigational radiopharmaceutical Lymphoseek injection, an intraoperative lymphatic mapping agent.

December 18, 2012

Theraclion receives CE Mark for EchoPulse

By AuntMinnieEurope.com staff writers

French echotherapy firm Theraclion has received the CE Mark for its high-intensity focused ultrasound (HIFU) device called EchoPulse, which is designed for the noninvasive treatment of breast fibroadenomas.

December 11, 2012

Mauna's UroFlex receives CE Mark

By AuntMinnieEurope.com staff writers

Mauna Kea Technologies' UroFlex confocal miniprobe has received CE Mark approval for use during cystoscopy procedures.

December 6, 2012

European vote paves the way for continued use of clinical MRI

By Philip Ward

After several years of uncertainty and deliberation over the regulations affecting MRI, a European Parliament committee voted on Thursday to exempt workers who deal with MRI from exposure limits contained in the Directive on Protecting Workers from Exposure to Electromagnetic Fields.

December 5, 2012

InSightec's ExAblate Neuro wins CE mark

By AuntMinnieEurope.com staff writers

InSightec announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the European CE Mark for the treatment of neurological disorders in the brain, including essential tremor, Parkinson's disease, and neuropathic pain.

December 5, 2012

New rules pave way for faster MR training for German cardiologists

By Frances Rylands-Monk

The prospect of more intense turf battles between cardiologists and radiologists in Germany is looming large following a change in the requirements for MRI certification at the local level. The new certificate takes only 12 months of training in a cardiology department and involves the reading of 300 MR images.

November 6, 2012

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

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