Regulatory: Page 15

Sectra gains CE Mark for image portal software
By AuntMinnieEurope.com staff writers
Swedish PACS firm Sectra has received the CE Mark for its Image Exchange Portal (Sectra IEP) software for the secure transfer of images and patient reports between hospitals.
May 12, 2015
RCR sends letter to health chief
By AuntMinnieEurope.com staff writers
The U.K's Royal College of Radiologists (RCR) has sent an open letter to the Secretary of State for Health Jeremy Hunt, who has been reappointed to the post following last week's general election.
May 12, 2015
RCR reaffirms position on imaging reporting IDs
By AuntMinnieEurope.com staff writers
The U.K. Royal College of Radiologists (RCR) has reaffirmed its position on the need to properly record the identity of healthcare professionals who report imaging investigations.
April 23, 2015
Germany's e-health bill gathers momentum
By AuntMinnieEurope.com staff writers
The German Radiology Society has announced its support for the federal government's draft e-health bill.
February 9, 2015
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
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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
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