Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2023
EndeavorRx, world’s first and only prescription video game treatment, secures FDA label expansion for paediatric ADHD patients aged 13-17
18 December 2023 - Akili’s clinically proven digital medicine now authorised for children 8-17, opening option to more patients as ...
Posted 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 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 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 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 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 ...
Posted by Michael Wonder on 15 Jun 2020
FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD
15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function ...
Posted by Michael Wonder on 27 Sep 2017
FDA selects participants for new digital health software pre-certification pilot program
26 September 2017 - Today, the U.S. FDA announced the names of the companies selected to participate in a first-of-its ...
Posted by Michael Wonder on 12 Sep 2017
Streamlined FDA reviews fail to catch dangerous glitches in health software, study finds
12 September 2017 - The FDA carefully polices many categories of drugs and devices. ...