Regulatory: Page 4

RaySearch brings RayStation 9 to China
By AuntMinnieEurope.com staff writers
Radiation therapy software developer RaySearch Laboratories has received regulatory clearance in China for its RayStation 9 software.
July 5, 2021
2019 09 17 16 52 3040 Raysearch Astro 2019
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
2020 02 24 17 44 7728 Clearance Stamp 400
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
2021 04 12 21 11 0603 Breast Cancer 3 D 400
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
2020 02 24 17 44 7728 Clearance Stamp 400
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
2017 12 01 19 30 7318 X Ray Chest Lungs 400b
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
2021 02 02 16 07 0283 Radiation Therapy Planning 400
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
2020 06 09 20 17 5049 Iaea 400
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
2016 08 02 15 17 42 85 Lungs Red Body 400
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
2020 10 26 23 08 4584 Doctor Woman Computer 400
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
2016 07 06 11 22 59 854 Eu Uk Split 400
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
2020 03 25 22 41 8535 Artificial Intelligence Ai Hand 400
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
2017 01 24 12 16 40 949 Brexit 400
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