Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
Posted by Michael Wonder on 16 Jul 2020
Actual and potential harm caused by medical software
16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...
Posted by Michael Wonder on 02 Jul 2020
Cochlear calls for low risk health apps to be exempt from TGA register
3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...
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 29 Apr 2020
Medicines Australia encourages 22,000 plus employees of the medicines industry to download the COVIDSafe app
29 April 2020 - As an economic and manufacturing leader in Australia, we pledge to encourage all our 22,000 + ...
Posted by Michael Wonder on 16 Apr 2020
EMA shares advice on validated computer systems used in clinical trials
16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used ...
Posted by Michael Wonder on 25 Mar 2020
Oracle providing White House with software to study unproven coronavirus drugs
24 March 2020 - The online platform could allow physicians to upload patient data on how malaria drugs perform on coronavirus ...
Posted by Michael Wonder on 17 Mar 2020
NICE publishes its first medtech briefing on artificial intelligence software
17 March 2020 - NICE publishes a Medtech Innovation Briefing on artificial intelligence for analysing CT brain scans. ...