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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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 ...

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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 ...

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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. ...

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Sydney Uni software helps hospitals cut medicine bill

25 July 2018 - A software platform developed at the University of Sydney could save Australia’s hospitals more than $100 ...

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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 ...

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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.  ...

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