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Regulatory: Page 3
SenseTime receives CE Mark for chest x-ray software
By
AuntMinnieEurope.com staff writers
Artificial intelligence development company SenseTime announced it has received the CE Mark for its SenseCare-Chest DR Pro diagnostic software.
April 14, 2021
DoseVue gets CE mark for invivo dosimetry product
By
AuntMinnieEurope.com staff writers
Belgian medical device company DoseVue has received the CE mark for its DoseWire Series 200 in-vivo dosimetry technology for radiation therapy.
February 1, 2021
IAEA launches project on software dosimetry
By
AuntMinnieEurope.com staff writers
The International Atomic Energy Agency (IAEA) has launched a project to investigate the use of software to assist radiology professionals with performing quality assurance and dosimetry on x-ray equipment.
January 14, 2021
Aidence receives CE Mark for lung nodule software
By
AuntMinnieEurope.com staff writers
Netherlands-based artificial intelligence firm Aidence has been granted the CE Mark for Veye Chest, the company's lung nodule management assistant software.
October 28, 2020
Oxford team warns of industry influence on AI regulation
By
Erik L. Ridley
A research group from the University of Oxford in the U.K. has highlighted the involvement of industry in comments on a proposed draft regulation of AI algorithms in the U.S. In an article posted online by
BMJ Open
, the authors have voiced concern about possible bias.
October 26, 2020
After Brexit: Device regulations come under scrutiny
By
Mike Pogose
The U.K. has produced advice on how to launch medical devices on the market after the Brexit transition period ends on 1 January 2021. Regulatory expert Mike Pogose discusses how the new procedures will affect imaging manufacturers and their customers.
September 14, 2020
AI software developers win big in U.K. initiative
By
Erik L. Ridley
Radiology-oriented artificial intelligence (AI) software figured prominently on the list of initial winners of the U.K. government's new AI in Health and Care Award, which will provide a total of 140Â million pounds (154.3Â million euros) in funding over three years to support the testing and evaluation of AI technology.
September 9, 2020
U.K. issues advice on post-Brexit device regulations
By
AuntMinnieEurope.com staff writers
The U.K. government has produced detailed guidance on how to place manufactured goods on the market in post-Brexit U.K.
September 2, 2020
U.K. increases funding for AI to diagnose disease
By
AuntMinnieEurope.com staff writers
The U.K. government said that it's investing an additional 50Â million pounds (56.2Â million euros) to scale up the efforts of its existing digital pathology and imaging artificial intelligence (AI) centers of excellence.
September 1, 2020
Thermal burns account for 60% of MRI adverse events
By
Wayne Forrest
Ten years of MRI adverse event reports show burns from coils and electrocardiography leads during scans are among the most common -- and preventable -- causes for patient injuries, according to a large study presented on Thursday at the International Society for Magnetic Resonance in Medicine meeting.
August 13, 2020
Guerbet brings Vectorio to Canadian market
By
AuntMinnieEurope.com staff writers
Contrast developer Guerbet has received approval to market its Vectorio contrast media kit in Canada for imaging of hepatocellular carcinoma.
May 21, 2020
EMA unveils new regulatory science strategy
By
AuntMinnieEurope.com staff writers
The European Medicines Agency (EMA) has published a plan outlining its regulatory science strategy in both human and veterinary medicines for the next five years.
March 31, 2020
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