Regulatory: Page 20

Elekta wins clearances for Versa HD upgrade
By AuntMinnieEurope.com staff writers
Radiation oncology firm Elekta has received the CE Mark and clearance from the U.S. Food and Drug Administration for new features for its Versa HD linear accelerator.
August 20, 2013
Hermes gets FDA nod for NM software
By AuntMinnieEurope.com staff writers
Swedish nuclear medicine software developer Hermes Medical Solutions has received U.S. Food and Drug Administration clearance for new software for reconstructing and processing hybrid nuclear medicine (NM) studies.
August 13, 2013
IMRIS gets CE Mark for intraoperative CT
By AuntMinnieEurope.com staff writers
Image-guided therapy developer IMRIS has received the CE Mark for its Visius iCT ceiling-mounted intraoperative CT scanner.
August 6, 2013
MR Instruments gets clearance for coil suite
By AuntMinnieEurope.com staff writers
MRI coil developer MR Instruments has received U.S. Food and Drug Administration 510(k) clearance, the European CE Mark, and Health Canada approval for its 1.5-tesla DuoFlex coil suite.
July 30, 2013
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
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