Regulatory: Page 11

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

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

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

EchoPixel secures CE Mark for virtual reality software

By AuntMinnieEurope.com staff writers

Advanced visualization developer EchoPixel has received the CE Mark for its True 3D Viewer virtual reality imaging software.

February 21, 2017

French radiology union delivers ultimatum

By AuntMinnieEurope.com staff writers

France's national union of independent radiologists (Fédération nationale de médecins radiologues, FNMR) has made an urgent plea to the general director of the national union of health insurers (Union nationale des caisses d'assurance maladie, UNCAM).

February 13, 2017

FNMR: 'Exceptional measure' threatens modern imaging

By AuntMinnieEurope.com staff writers

France's national union of independent radiologists (Fédération nationale de médecins radiologues, FNMR) has reacted strongly again to news that the National Assembly has voted to re-establish Article 52 bis of the draft bill for the 2017 social security budget (PLFSS 2017).

December 5, 2016

French reimbursement row intensifies

By AuntMinnieEurope.com staff writers

France's national union of independent radiologists (Fédération nationale de médecins radiologues, FNMR) has again voiced its anger over the proposed changes to reimbursement policy.

November 22, 2016

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