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Regulatory: Page 12
Siemens receives seal of approval for teamplay
By
AuntMinnieEurope.com staff writers
Siemens Healthineers said its teamplay cloud-based platform has been awarded the German Seal of Privacy for IT products and the European Privacy Seal.
October 18, 2016
Bracco secures MultiHance approval for whole-body MRI
By
AuntMinnieEurope.com staff writers
Bracco Imaging has received approval from the U.K.'s Medicines and Healthcare products Regulatory Agency for the use of its MultiHance MRI agent for whole-body exams in both adults and children.
September 21, 2016
ViewRay's MRIdian Linac gets CE Mark
By
AuntMinnieEurope.com staff writers
Image-guided therapy developer ViewRay received the CE Mark for its next-generation linear accelerator-based MRI-guided radiation therapy system, the MRIdian Linac.
September 19, 2016
Patient group applauds EU deal on medical devices
By
AuntMinnieEurope.com staff writers
The European Patients' Forum said it welcomes last week's political agreement on the regulation of medical devices, although not without some reservations.
May 31, 2016
ITM moves closer to clearance for EndolucinBeta
By
AuntMinnieEurope.com staff writers
German radiopharmaceutical firm ITM Isotopen Technologies said a European Medicines Agency (EMA) committee has recommended marketing authorization for the company's EndolucinBeta radiopharmaceutical precursor.
May 10, 2016
U.K. releases new guidelines on PET/CT
By
Philip Ward
The U.K. Royal College of Radiologists (RCR) and Royal College of Physicians have issued revised recommendations on the best use of PET/CT. The 34-page document can be downloaded free of charge from the RCR's website, and it includes a comprehensive bibliography.
May 10, 2016
Acutus Medical receives CE Mark for 2 products
By
AuntMinnieEurope.com staff writers
Heart rhythm software developer Acutus Medical has received the CE Mark for its AcQMap high-resolution imaging and mapping system, as well as its AcQMap catheter.
May 4, 2016
COCIR urges quick action on data protection
By
AuntMinnieEurope.com staff writers
The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) is urging European Union (EU) member states to quickly harmonize interpretation and enforcement of its data protection regulation.
April 14, 2016
Planmed receives CE Mark for mammo systems
By
AuntMinnieEurope.com staff writers
Medical imaging vendor Planmed received the CE Mark for its digital breast tomosynthesis system and full-field digital mammography system.
April 10, 2016
China clears EOS digital x-ray system
By
AuntMinnieEurope.com staff writers
Orthopedic digital imaging developer EOS Imaging received clearance from the China State Food and Drug Administration to market its EOS product in the country.
March 21, 2016
EOS gets CE Mark for spineEOS
By
AuntMinnieEurope.com staff writers
Orthopedic digital imaging developer EOS Imaging has received the CE Mark for its spineEOS online 3D surgical planning software for the EOS system.
March 4, 2016
Medtronic gets CE Mark for MRI-safe defibrillators
By
AuntMinnieEurope.com staff writers
Interventional device developer Medtronic has received the CE Mark for its cardiac resynchronization therapy defibrillators for 3-tesla MRI scans.
February 22, 2016
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