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Regulatory: Page 12
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
Alpinion nets CE Mark for HIFU system
By
AuntMinnieEurope.com staff writers
Korean ultrasound technology developer Alpinion Medical Systems has received the CE Mark for its Alpius 900 ultrasound-guided high intensity focused ultrasound (HIFU) system for the treatment of uterine fibroids.
February 16, 2016
Fuji VisualSonics gets CE Mark for Vevo MD
By
AuntMinnieEurope.com staff writers
Ultrasound developer Fujifilm VisualSonics has received the CE Mark for its Vevo MD ultrahigh-frequency clinical ultrasound system.
January 10, 2016
Varian gets Saudi OK for proton therapy system
By
AuntMinnieEurope.com staff writers
Radiation therapy firm Varian Medical Systems has received clearance from the Saudi Food and Drug Authority (FDA) to market its ProBeam proton therapy system.
January 10, 2016
European Commission to draft new cybersecurity law
By
AuntMinnieEurope.com staff writers
The European Commission has announced it will draft new legislation requiring healthcare providers to take stronger security measures and report breaches to the authorities.
December 8, 2015
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