Regulatory: Page 20

Elekta gets CE Mark for prostate motion monitoring
By AuntMinnieEurope.com staff writers
Radiation oncology firm Elekta has received a CE Mark for its Clarity 4D monitoring system.
July 18, 2013
GE gets CE Mark for breast tomosynthesis product
By AuntMinnieEurope.com staff writers
GE Healthcare has received the CE Mark for its SenoClaire breast tomosynthesis package.
July 16, 2013
Sectra registers dose-tracking software with FDA
By AuntMinnieEurope.com staff writers
PACS firm Sectra has registered its Sectra DoseTrack dose-tracking software with the U.S. Food and Drug Administration.
July 9, 2013
Unpaid overtime and long working hours persist
By Philip Ward
A third of radiologists typically work more than 50 hours a week, and almost 10% of them work more than 60 hours per week. The majority tend to start work at around 8 a.m. or earlier, and do an average of one on-call session per week, AuntMinnieEurope.com's survey has found.
June 27, 2013
2013 06 27 09 57 50 939 Exhausted Businessman 200
Revised EMF Directive draws praise from COCIR
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) has applauded the European Council's adoption of the revised Directive on Protecting Workers from Exposure to Electromagnetic Fields (EMF Directive).
June 23, 2013
EDAP gets CE Mark for Focal.One
By AuntMinnieEurope.com staff writers
French therapeutic ultrasound developer EDAP TMS has received the CE Mark for its Focal.One robotic high-intensity focused ultrasound device.
June 17, 2013
Alliance for MRI praises EU's MRI report
By AuntMinnieEurope.com staff writers
The Alliance for MRI is praising the European Parliament's approval of an amendment for MRI use in its draft report on the revised Directive on Protecting Workers from Exposure to Electromagnetic Fields, the Alliance said.
June 11, 2013
BMJ: Medical device regulation not strong enough
By AuntMinnieEurope.com staff writers
Proposals for the European Union to change the way it regulates medical devices do not go far enough to ensure safe and effective patient care, according to a commentary published online on 7 May in the British Medical Journal (BMJ).
May 7, 2013
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
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