Regulatory: Page 4

Global regulators unveil initiative on development of safe AI
By AuntMinnieEurope.com staff writers
The U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.'s Medicines and Healthcare products Regulatory Agency have jointly issued a list of guiding principles for developers of medical devices based on artificial intelligence (AI) and machine learning.
October 26, 2021
2021 10 27 21 02 0378 Fda Button 400
Baxter, BioMerieux receive CE Mark for kidney test
By AuntMinnieEurope.com staff writers
Baxter International and BioMerieux have received the CE Mark for the Nephroclear CCL14 Test, which predicts persistent severe acute kidney injury.
October 21, 2021
2019 12 21 00 26 9702 Kidneys 400
Radiobotics gets FDA clearance for knee OA algorithm
By AuntMinnieEurope.com staff writers
Artificial intelligence (AI) software developer Radiobotics has secured U.S. Food and Drug Administration 510(k) clearance for RBknee, an AI-based software application designed to aid in the diagnosis of knee osteoarthritis (OA) on radiography.
August 30, 2021
2019 12 09 17 23 6730 Artificial Intelligence Ai Suit 400
Radiobotics receives European certification
By AuntMinnieEurope.com staff writers
Radiobotics announced the company has been certified according to the new European Medical Device Regulations and ISO 13485. The Danish vendor's product RBknee has also received the CE Mark under regulations as a class IIA medical device.
July 11, 2021
2019 05 24 21 11 2720 Denmark Flag Button 400
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
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