Regulatory: Page 6

COCIR: Clock is ticking on MDR countdown
By AuntMinnieEurope.com staff writers
The European medical device community has one year to go until the Medical Device Regulation (MDR) goes into effect, but little progress has been made toward implementation of the regulatory scheme, according to the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR).
June 6, 2019
QUIBIM secures CE Mark for chest x-ray algorithm
By AuntMinnieEurope.com staff writers
Advanced image analysis software developer QUIBIM has received the CE Mark for its Chest X-Ray Classification software application.
May 27, 2019
EMA struggles with staffing issues after relocation
By AuntMinnieEurope.com staff writers
The European Medicines Agency (EMA) has acknowledged that it will require several more months to rebuild its workforce following its recent relocation from London to Amsterdam due to Brexit.
March 24, 2019
Spain probes anticompetitive PET practices
By AuntMinnieEurope.com staff writers
Spanish authorities have launched disciplinary proceedings against French molecular imaging firm Advanced Accelerator Applications and global nuclear medicine firm Curium for alleged anticompetition practices in Spain.
February 13, 2019
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
2017 12 15 22 08 5117 Ge Rsna 2017 400
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
2019 01 14 19 03 8543 Quibim Precision 20190114192522
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
2018 08 28 18 59 9066 Artificial Intelligence Ai 400
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
2018 07 20 22 27 4483 Australian Flag 400
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
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