Regulatory: Page 21

Eucomed launches medical device reimbursement website
By AuntMinnieEurope.com staff writers
The European medical technology industry association Eucomed has launched a reimbursement website that provides information about reimbursement for medical devices and a visual overview of national reimbursement systems in Europe.
March 18, 2013
MHRA approves Bracco's MultiHance for breast MRI
By AuntMinnieEurope.com staff writers
Bracco Imaging has received approval from the U.K. Medicines and Health Care Products Regulatory Agency (MHRA) for expanded labeling of its MultiHance MRI agent, the company said.
March 12, 2013
'Unfair' regulatory stance on radiotracers poses threat to PET's future
By Becky McCall
VIENNA - Legal and regulatory issues surrounding the production and uses of radiotracers represent a significant threat to PET imaging, a senior luminary told ECR 2013 attendees at Sunday's professional challenges session on the legal matters related to multimodality techniques.
March 10, 2013
2013 03 11 14 43 21 277 2013 03 11 Von Schulthess 70
ESC applauds EC medical device regulation proposals
By AuntMinnieEurope.com staff writers
The European Society of Cardiology (ESC) said that the European Commission's proposal for a new regulation to govern the evaluation and approval of medical devices in Europe is an important step toward improving patient safety.
March 7, 2013
GE gets CE Mark for SilentScan MRI mode
By AuntMinnieEurope.com staff writers
GE Healthcare has received the CE Mark for SilentScan, an MRI scanning mode that reduces scanning noise dramatically.
March 7, 2013
FDA clears Philips' live image-guidance tool
By AuntMinnieEurope.com staff writers
Royal Philips Electronics, parent company of Philips Healthcare, announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its EchoNavigator live image-guidance tool.
March 4, 2013
U.K. groups offer new guidance on patient records
By AuntMinnieEurope.com staff writers
BCS, the Chartered Institute for IT, and the U.K. Department of Health have released a new guidance leaflet for the public on how to keep their online health and social records safe and secure.
February 26, 2013
Device industry bodies add support to transatlantic partnership
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry and the Medical Imaging & Technology Alliance are supporting U.S. President Barack Obama's call for discussions around a Transatlantic Trade and Investment Partnership with the European Union.
February 14, 2013
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
Previous Page
Page 21 of 34
Next Page