Regulatory: Page 21

GE gets clearance for MR therapy planning suite
By AuntMinnieEurope.com staff writers
GE Healthcare has received U.S. Food and Drug Administration 510(k) clearance and the European CE Mark for its 1.5-tesla GEM RT Open Head & Neck Suite.
April 17, 2013
GE asks for EU manufacturing permission for Optison
By AuntMinnieEurope.com staff writers
GE Healthcare said it has applied to the European Medicines Agency to amend its marketing authorization to allow the company to manufacture its Optison echocardiography contrast agent at its own facility in Norway.
March 28, 2013
Europe offers plenty of opportunities for digital health IT start-ups
By Cynthia E. Keen
Does Europe offer a strong environment for digital healthcare companies to flourish? Or should entrepreneurs go to North America instead? Despite some obstacles, Europe offers ample opportunity for digital health entrepreneurs.
March 25, 2013
Piramal's florbetaben PET agent to be reviewed
By AuntMinnieEurope.com staff writers
Piramal Imaging said that the U.S. Food and Drug Administration and the European Medicines Agency have accepted the company's applications for review of its florbetaben investigational PET amyloid imaging agent.
March 20, 2013
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
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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
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