18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. ...
15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...
3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...
15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function ...
29 April 2020 - As an economic and manufacturing leader in Australia, we pledge to encourage all our 22,000 + ...
16 April 2020 - The EMA has published a notice about validating and qualifying all types of computerised systems used ...
24 March 2020 - The online platform could allow physicians to upload patient data on how malaria drugs perform on coronavirus ...
17 March 2020 - NICE publishes a Medtech Innovation Briefing on artificial intelligence for analysing CT brain scans. ...
25 July 2018 - A software platform developed at the University of Sydney could save Australia’s hospitals more than $100 ...
26 September 2017 - Today, the U.S. FDA announced the names of the companies selected to participate in a first-of-its ...
12 September 2017 - The FDA carefully polices many categories of drugs and devices. ...