Regulatory: Page 10

Report: European regulators eye timing of Canon deal
By AuntMinnieEurope.com staff writers
Reuters is reporting that Canon's acquisition of Toshiba Medical in 2016 is among several recent corporate mergers and acquisitions that are being reviewed by European regulators for possible violations of antitrust rules in the European Union (EU).
July 6, 2017
2017 07 07 10 47 37 369 Canon Ecr 2017 20170707174811
French group announces 9-point plan of action
By Frances Rylands-Monk
France's national union of private radiologists (Fédération Nationale des Médecins Radiologues, FNMR) unveiled its new independent medical imaging project. The plan lists nine major areas on which urgent action is necessary, said FMNR President Dr. Jean-Philippe Masson.
June 28, 2017
2017 06 29 08 46 45 427 2017 06 29 Masson Thumb
EMA begins work on Brexit
By AuntMinnieEurope.com staff writers
At its June 2017 meeting, the management board of the European Medicines Agency (EMA) received an update on preparations for withdrawal of the U.K. form the European Union (EU) based on the U.K.'s invocation of Article 50 in March.
June 19, 2017
Biotronik receives new CE Mark for pacemakers
By AuntMinnieEurope.com staff writers
Biomedical device company Biotronik has received the CE Mark for the use of its Edora, Evity, and Enitra series of pacemakers with 3-tesla MRI scanners.
June 13, 2017
German experts assess impact of new radiation law
Radiation protection and cancer imaging feature prominently on the agenda for the 98th German Radiology Congress, which takes place in Leipzig from 24 to 27 May. As part of our buildup to the conference, we have interviews on these two topics.
May 8, 2017
2017 05 08 12 19 42 805 Leipzig2 400
SyntheticMR gets CE Mark for myelin volume feature
By AuntMinnieEurope.com staff writers
Swedish medical imaging software developer SyntheticMR has received the CE Mark for its REMyDI (Rapid Estimation of Myelin for Diagnostic Imaging) feature.
April 18, 2017
PRAC committee agrees to review gadolinium decision
By AuntMinnieEurope.com staff writers
A European regulatory committee that recommending pulling four linear-based gadolinium MRI contrast agents off the market said it has agreed to review the decision.
April 6, 2017
COCIR praises Europe's new medical device framework
By AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) has given its blessing to the new regulatory framework for medical devices, the Medical Device Regulation (MDR), which was approved in a vote on 5 April during a plenary session of the European Parliament.
April 4, 2017
U.K. radiologist admits to fraud charges in overtime case
By AuntMinnieEurope.com staff writers
A U.K. radiologist received a suspended prison sentence in a case in which he was accused of misrepresenting the time he read x-ray studies in order to receive overtime pay from the National Health Service (NHS).
March 28, 2017
GE requests review of European gadolinium ruling
By AuntMinnieEurope.com staff writers
GE Healthcare has requested a review of a recommendation by a European regulatory committee that recommends the suspension of the marketing authorization for one of its gadolinium-based MRI contrast agents.
March 16, 2017
Pull linear MRI contrast from market, European group says
By Brian Casey and Wayne Forrest
In a stunning development, a European Union regulatory body on Friday recommended that four gadolinium-based contrast agents for MRI scans be pulled off the market due to concerns about gadolinium remaining in the body years after scans occur. The agents affected include some of the most widely used contrast products in medical imaging.
March 9, 2017
2016 10 04 14 10 28 621 Gadolinium 400
Medtronic gets CE Mark for MRI-compatible pacemakers
By AuntMinnieEurope.com staff writers
Medtronic has received the CE Mark for its SureScan family of quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps) that allow patients implanted with the devices to undergo MRI scans.
February 23, 2017
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