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RSS FeedPosted by Michael Wonder on 28 Sep 2022
In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices
27 September 2022 - The FDA on Tuesday published a list of artificial intelligence tools that should be regulated as ...
Posted by Michael Wonder on 14 Sep 2022
Potrero Medical receives FDA breakthrough device designation for Accuryn AKI predict algorithm
13 September 2022 - Potrero Medical announced today that the FDA granted breakthrough device designation for their AKI Predict machine learning ...
Posted by Michael Wonder on 12 Sep 2022
FDA grants breakthrough device designation for CurveBeam AI's OssView bone fragility software
12 September 2022 - CurveBeam announced its medical diagnostic software, OssView, has received US FDA breakthrough device designation. ...
Posted by Michael Wonder on 16 Aug 2022
Visibly becomes first FDA cleared online vision test in the United States
16 August 2022 - Visibly is excited to announce that, as of 12 August 2022, it has received 510(k) clearance ...
Posted by Michael Wonder on 12 Jul 2022
Healthy.io receives landmark FDA clearance for first and only smartphone powered home kidney test
12 July 2022 - As first test to receive FDA clearance across all current iOS and Android smartphone devices, Minuteful ...
Posted by Michael Wonder on 23 May 2022
NICE recommends offering app-based treatment for people with insomnia instead of sleeping pills
20 May 2022 - Hundreds of thousands of people suffering from insomnia who would usually be prescribed sleeping pills could be ...
Posted by Michael Wonder on 24 Feb 2022
Viz.ai receives FDA 510(k) clearance for Viz Aneurysm
24 February 2022 - Viz.ai today announced it has received U.S. FDA 510(k) clearance for Viz Aneurysm. ...
Posted by Michael Wonder on 13 Feb 2022
How is NICE supporting digital health technology developers?
10 February 2022 - From sensor-enabled glasses that facilitate self-management for major depression to devices that measure muscle performance to ...
Posted by Michael Wonder on 21 Sep 2021
FDA authorises software that can help identify prostate cancer
21 September 2021 - Today, the U.S. FDA authorised marketing of software to assist medical professionals who examine body tissues (pathologists) ...
Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
Posted by Michael Wonder on 21 Apr 2021
FDA: make medical apps reliable, not risky
21 April 2021 - The fear of Covid-19 catapulted symptom checkers from the periphery of public attention to the center. ...
Posted by Michael Wonder on 19 Apr 2021
FDA issues final rule removing certain software from medical device regulations
19 April 2021 - The US FDA has issued a final rule making that eliminates certain software intended to transfer, ...
Posted by Michael Wonder on 19 Feb 2021
Clinical decision support software
18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. ...
Posted by Michael Wonder on 15 Jan 2021
Regulation of software based medical devices
15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...