Regulatory: Page 7

Oxipit gets CE Mark for ChestEye software

By AuntMinnieEurope.com staff writers

Artificial intelligence (AI) software developer Oxipit has received the CE Mark for ChestEye, its suite of analysis and reporting software for 75 common radiology findings.

February 5, 2019

GE gets EMA clearance for Rapiscan stressor in FFR

By AuntMinnieEurope.com staff writers

GE Healthcare announced that the European Medicines Agency (EMA) has approved its Rapiscan (regadenoson) pharmacological stress agent for on-label use in measuring fractional flow reserve (FFR) to identify hemodynamically or functionally significant stenosis.

January 28, 2019

QUIBIM awarded CE Mark for image analysis platform

By AuntMinnieEurope.com staff writers

Advanced image analysis firm QUIBIM has received CE Mark certification for its Precision image analysis platform.

January 13, 2019

Regulation needed to ensure safe use of AI in radiology

By Erik L. Ridley

Proper regulation is needed to ensure that artificial intelligence (AI) software is used safely, ethically, and appropriately with protection of patient privacy in radiology, according to Italian researchers in a review article recently published online in Insights into Imaging.

August 28, 2018

Australian agency orders review of Mo-99 procedures

By Brian Casey

An Australian government agency has ordered a review of radiation safety procedures at another federal agency in charge of running the nuclear reactor that was forced to stop shipments of the radioisotope molybdenum-99 (Mo-99) last month. The halt has spurred an ongoing shortage of important radiopharmaceuticals in the country.

July 26, 2018

SuperSonic gets regulatory seal of approval

By AuntMinnieEurope.com staff writers

The U.S. Food and Drug Administration (FDA) has cleared ultrasound technology developer SuperSonic Imagine's Aixplorer Mach 30 system. The company has also received the European CE Mark for the device, it said.

July 16, 2018

Neural Analytics wins CE Mark for robotic ultrasound

By AuntMinnieEurope.com staff writers

Medical robotics company Neural Analytics has received the CE Mark for its NeuralBot robotic ultrasound technology.

July 5, 2018

Brexit concerns remain in the U.K.

By AuntMinnieEurope.com staff writers

Healthcare providers in the U.K. continue to voice their concerns over the coming consummation of Brexit in March 2019, when the nation is set to leave the European Union.

July 1, 2018

FDA clears new version of Plum Medical workstation

By AuntMinnieEurope.com staff writers

German mobile image display developer Plum Medical Solutions has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an upgraded version of its Med-Tab portable medical imaging workstation.

June 25, 2018

COCIR applauds new data storage rules

By AuntMinnieEurope.com staff writers

The European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) applauds new rules that encourage nonpersonal data to be stored and processed anywhere in the European Union.

June 24, 2018

Elekta receives CE Mark for new MR/RT system

By AuntMinnieEurope.com staff writers

Radiation oncology vendor Elekta has received the CE Mark for its Elekta Unity MR/radiation therapy (MR/RT) system.

June 17, 2018

Why patient communication's central to better cancer care

By Leo Cendrowicz

BRUSSELS - Effective communication among radiologists, referring physicians, and patients is essential to advance care, Lieve Wierinck, a Belgian Member of the European Parliament and cancer survivor, told attendees at a special seminar held on 6 June.

June 7, 2018

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