Regulatory: Page 16

Koning secures Australian breast CT clearance
By AuntMinnieEurope.com staff writers
Koning has received the Australian Register of Therapeutic Goods Certificate for its Koning Breast CT system and biopsy add-on option.
October 2, 2014
CFI gets CE Mark for radiation body shield
By AuntMinnieEurope.com staff writers
CFI Medical has received CE Mark approval for its Zero-Gravity suspended body shield for radiation protection.
September 30, 2014
St. Jude gets CE Mark for updated labeling of pacing leads
By AuntMinnieEurope.com staff writers
St. Jude Medical announced CE Mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads, which allows existing and future patients with the devices access to MR imaging.
September 22, 2014
Oxford instruments gets new CT approval for Korea
By AuntMinnieEurope.com staff writers
U.K.-based after-market CT scanner provider Oxford Instruments Healthcare said it has received approval from the Korean Food and Drug Administration (KFDA) to market its refurbished GE Healthcare CT equipment and parts.
September 14, 2014
EOS gains Brazilian approval
By AuntMinnieEurope.com staff writers
Orthopedic digital imaging developer EOS Imaging has received approval from the Brazilian National Health Surveillance Agency to market its EOS digital x-ray system in the country.
September 9, 2014
GE's Vizamyl gets European OK
By AuntMinnieEurope.com staff writers
GE Healthcare has received clearance from the European Commission to market Vizamyl.
September 1, 2014
Acusphere pulls European bid for Imagify contrast
By AuntMinnieEurope.com staff writers
Ultrasound contrast developer Acusphere has voluntarily withdrawn a regulatory application in Europe for its Imagify ultrasound contrast agent for the detection of coronary artery disease.
August 27, 2014
Specialist certification gets easier in Germany
Changes to the training system are having major implications for radiologists in Germany. In this interview, Dr. Reinhard Loose, PhD, head of the Radiological Protection Commission Working Group of the German Radiological Society, discusses the certification requirements introduced in summer 2012.
August 21, 2014
2014 08 21 11 13 36 549 2014 08 22 Loose Thumb
Acertara obtains CE Mark
By AuntMinnieEurope.com staff writers
Ultrasound acoustic measurement and testing firm Acertara Acoustic Laboratories has received the CE Mark for its Aureon ultrasound probe testing device.
July 28, 2014
IMRIS gets CE Mark for surgical theater upgrade
By AuntMinnieEurope.com staff writers
IMRIS has received the CE Mark for integration of the next generation of its core MRI technology into its Visius Surgical Theatre.
July 22, 2014
Australian health service finds lapse in x-ray reporting
By AuntMinnieEurope.com staff writers
The Queensland Government in Australia said it has been asked to appoint an independent expert to review issues associated with plain x-ray reporting at Gold Coast University and Robina hospitals.
July 21, 2014
CorTech Labs' NeuroQuant nets CE Mark
By AuntMinnieEurope.com staff writers
Brain imaging software developer CorTechs Labs has received the CE Mark to distribute its NeuroQuant application in Europe.
July 8, 2014
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