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Regulatory: Page 2
Circle nets clearance for AI stroke detection software
By
AuntMinnieEurope.com staff writers
Cardiac imaging software developer Circle Cardiovascular Imaging subsidiary Circle Neurovascular Imaging has received clearance for its StrokeSens acute stroke detection software from Health Canada and the Therapeutic Goods Administration in Australia.
February 14, 2022
Motilent gets FDA clearance for AI gut imaging software
By
AuntMinnieEurope.com staff writers
U.K.-based artificial intelligence (AI) software developer Motilent has received U.S. Food and Drug Administration (FDA) 510(k) clearance for GIQuant, an MR image analysis application for evaluating gastrointestinal function in digestive diseases.
December 13, 2021
AMRA Medical gets FDA clearance for MasS Scan
By
AuntMinnieEurope.com staff writers
Swedish image analysis software developer AMRA Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Muscle Assessment Score (MAsS) Scan software.
December 6, 2021
Esaote obtains EC certification for new open MRI
By
AuntMinnieEurope.com staff writers
Esaote has obtained European Commission (EC) Medical Devices Regulation certification for its new Magnifico Open total-body MR machine.
November 29, 2021
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
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
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
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
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
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
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