Regulatory: Page 15

Nevro gets CE Mark for new MR-compatible labeling

By AuntMinnieEurope.com staff writers

Medical device firm Nevro has received the European CE Mark for expanded MRI-conditioned labeling of its Senza implantable spinal cord stimulation system.

February 4, 2015

COCIR, European Parliament call for better healthcare

By AuntMinnieEurope.com staff writers

The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) and Françoise Grossetête, member of the European Parliament, launched a call to action for better healthcare delivery in the European Union on 2 February.

February 4, 2015

ITG gets approval for gallium-68 generator

By AuntMinnieEurope.com staff writers

German firm Isotope Technologies Garching (ITG) has received manufacturing authorization from the regional government of Upper Bavaria for its gallium-68 (Ga-68)/germanium-68 (Ge-68) generator.

January 13, 2015

Eckert & Ziegler gets German approval for gallium-68 generator

By AuntMinnieEurope.com staff writers

Isotope technology firm Eckert & Ziegler received approval from the Federal Institute for Drugs and Medical Devices for its pharmaceutical germanium-68 (Ge-68)/gallium-68 (Ga-68) generator for the German market.

December 7, 2014

FDA clears SuperSonic probes

By AuntMinnieEurope.com staff writers

SuperSonic Imagine has received U.S. Food and Drug Administration (FDA) 510(k) clearance for two new probes used with its Aixplorer ultrasound system.

December 1, 2014

Europe adopts U.K. guidelines for imaging child abuse

By Rebekah Moan

The European Society of Pediatric Radiology (ESPR) has adopted the U.K. guidelines for determining the best imaging strategy in suspected cases of nonaccidental injury in children. The chair of the ESPR's Child Abuse Task Force, Dr. Amaka Offiah, has called this a "major development."

November 23, 2014

Lymphoseek earns EU marketing authorization

By AuntMinnieEurope.com staff writers

Navidea Biopharmaceuticals has received marketing authorization in the European Union (EU) for its Lymphoseek 250-mcg kit for radiopharmaceutical preparation.

November 20, 2014

ViewRay's MRIdian scores CE Mark

By AuntMinnieEurope.com staff writers

Image-guided therapy developer ViewRay has received the CE Mark for its MRIdian MRI-guided radiation therapy device.

November 11, 2014

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

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