Regulatory: Page 10

Mazor gets CE Mark for Mazor X
By AuntMinnieEurope.com staff writers
Surgical navigation software developer Mazor Robotics has obtained the CE Mark for its Mazor X surgical assurance platform.
September 19, 2017
Guerbet issues statement on FDA gadolinium vote
By AuntMinnieEurope.com staff writers
Contrast agent manufacturer Guerbet has issued a statement regarding gadolinium retention from MRI contrast media following today's meeting of the U.S. Food and Drug Administration's (FDA) Medical Imaging Drugs Advisory Committee.
September 7, 2017
DRG publishes overview of German radiation law
By AuntMinnieEurope.com staff writers
The German Radiological Society (DRG) has published an overview of the new Radiological Protection Act, which was approved by the German Parliament on 27 June and becomes effective on 1 October.
August 29, 2017
Siemens 7T MRI gets CE Mark for clinical use
By AuntMinnieEurope.com staff writers
Siemens Healthineers has received the European CE Mark for clinical use of its 7-tesla Magnetom Terra MRI scanner.
August 24, 2017
2017 03 07 17 10 32 942 Siemens Rsna 2016 Square 20170308001119
Medtronic secures CE Mark for MRI device
By AuntMinnieEurope.com staff writers
Medtronic has received the CE Mark for its Attain Stability Quad MRI SureScan left heart lead.
August 22, 2017
New controversy emerges over gadolinium contrast agents
By Frances Rylands-Monk
New guidelines on nephrogenic systemic fibrosis have prompted a strong reaction from radiologists and caused the author to consider revising his recommendations in a bid to restore the peace. He must take full account of a recent ruling on gadolinium-based contrast agents, Dr. Henrik Thomsen said.
August 15, 2017
2017 08 15 11 18 12 574 2017 08 16 Nsf Thomsen Thumb
Use of 'less than' symbol causes Irish computer glitch
By AuntMinnieEurope.com staff writers
Thousands of medical imaging scans in the Republic of Ireland may have to be repeated due to a computer glitch in the country's health system network, according to an article published on 3 August in the Irish Times.
August 3, 2017
Germany approves Radiology Protection Act
By AuntMinnieEurope.com staff writers
The German Parliament has given its official approval to the country's first Radiological Protection Act, according to an article on the German Radiological Society website.
July 10, 2017
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
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