Regulatory: Page 16

ESR makes reform plea to new EU leaders

By Leo Cendrowicz

BRUSSELS - Europe's fast-evolving radiology sector needs common standards in quality, safety, training, and research, or risks seeing imaging procedures become chaotic, expensive, and dangerous, the European Society of Radiology (ESR) warned in Brussels on 4 November.

November 4, 2014

GE receives CE Mark for Signa PET/MR system

By AuntMinnieEurope.com staff writers

GE Healthcare has received the CE Mark for its Signa PET/MR system.

November 3, 2014

COCIR makes recommendations for health tech assessment

By AuntMinnieEurope.com staff writers

The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) is issuing new recommendations for health technology assessment agencies during the HTA 2.0 Europe meeting.

November 2, 2014

EOS receives approval to market in South Korea

By AuntMinnieEurope.com staff writers

EOS Imaging has received approval from the Korean Food and Drug Administration to market its system in South Korea.

October 27, 2014

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

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