Regulatory: Page 4

Interventional Systems gets FDA nod for medical robot

By AuntMinnieEurope.com staff writers

Austrian firm Interventional Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Micromate medical robot.

June 28, 2021

iCAD receives CE Mark for ProFound AI for DBT 3.0

By AuntMinnieEurope.com staff writers

Computer-aided detection (CAD) software developer iCAD has received the CE Mark for version 3.0 of its ProFound AI for digital breast tomosynthesis (DBT) software.

June 14, 2021

Kheiron brings Mia to Australia, New Zealand

By AuntMinnieEurope.com staff writers

Artificial intelligence software developer Kheiron Medical Technologies has received clearance for its Mia mammography breast cancer screening software in Australia and New Zealand.

June 14, 2021

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 140 million pounds (154.3 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 50 million pounds (56.2 million euros) to scale up the efforts of its existing digital pathology and imaging artificial intelligence (AI) centers of excellence.

September 1, 2020

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