Regulatory: Page 22

Varian gets FDA clearances, Algerian order
By AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration for two of the company's products.
January 23, 2013
St. Jude obtains CE Mark approval for ICE catheter
By AuntMinnieEurope.com staff writers
Cardiac technology developer St. Jude Medical has received the European CE mark for its ViewFlex Xtra intracardiac echocardiography (ICE) catheter used for cardiac ablation procedures.
January 20, 2013
Russia amends medical device regulations
By AuntMinnieEurope.com staff writers
Medical device registrations submitted to Russian medical device market regulator Roszdravnadzor now must adhere to new requirements, and applicants seeking registration under the previous rule must provide a written statement to the agency as soon as possible.
January 17, 2013
Lilly's Amyvid PET agent gets European clearance
By AuntMinnieEurope.com staff writers
Eli Lilly and its subsidiary Avid Radiopharmaceuticals have received approval from the European Commission for their Amyvid (florbetapir F-18) radiopharmaceutical.
January 15, 2013
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
2011 11 09 10 02 55 619 Eu Flag 70
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
2012 11 06 12 50 03 763 Germany 70
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