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 ...

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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.  ...

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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 ...

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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) ...

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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 ...

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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.  ...

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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, ...

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Clinical decision support software

18 February 2021 - From 25 February 2021, the way that software-based medical devices are regulated in Australia will change. ...

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Regulation of software based medical devices

15 January 2021 - The TGA has updated its guidance on the regulation of software as a medical device. ...

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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 ...

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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 ...

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Actual and potential harm caused by medical software

16 July 2020 - TGA publishes a rapid literature review of safety and performance issues. ...

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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 ...

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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 ...

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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 + ...

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