Regulatory: Page 3

FDA issues new draft cybersecurity guidance

By AuntMinnieEurope.com staff writers

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance addressing cybersecurity in medical devices.

April 10, 2022

Oxipit secures CE Mark for autonomous imaging AI

By AuntMinnieEurope.com staff writers

Artificial intelligence (AI) software developer Oxipit's ChestLink software for chest x-rays has received the CE Mark.

March 28, 2022

MedTrace Pharma prepares phase III trial for O-15 PET

By AuntMinnieEurope.com staff writers

Danish PET technology developer MedTrace Pharma has received an investigational new drug exemption from the U.S. Food and Drug Administration, paving the way for a clinical trial to assess the firm's radioactive water (oxygen-15 water) PET imaging technique in detecting coronary artery disease.

March 21, 2022

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

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