20 May 2022 - Hundreds of thousands of people suffering from insomnia who would usually be prescribed sleeping pills could be ...
24 February 2022 - Viz.ai today announced it has received U.S. FDA 510(k) clearance for Viz Aneurysm. ...
10 February 2022 - From sensor-enabled glasses that facilitate self-management for major depression to devices that measure muscle performance to ...
21 September 2021 - Today, the U.S. FDA authorised marketing of software to assist medical professionals who examine body tissues (pathologists) ...
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
21 April 2021 - The fear of Covid-19 catapulted symptom checkers from the periphery of public attention to the center. ...
19 April 2021 - The US FDA has issued a final rule making that eliminates certain software intended to transfer, ...
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 + ...