EndeavorRx, world’s first and only prescription video game treatment, secures FDA label expansion for paediatric ADHD patients aged 13-17

18 December 2023 - Akili’s clinically proven digital medicine now authorised for children 8-17, opening option to more patients as ...

Read more →

In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices

27 September 2022 - The FDA on Tuesday published a list of artificial intelligence tools that should be regulated as ...

Read more →

Potrero Medical receives FDA breakthrough device designation for Accuryn AKI predict algorithm

13 September 2022 - Potrero Medical announced today that the FDA granted breakthrough device designation for their AKI Predict machine learning ...

Read more →

FDA grants breakthrough device designation for CurveBeam AI's OssView bone fragility software

12 September 2022 - CurveBeam announced its medical diagnostic software, OssView, has received US FDA breakthrough device designation.  ...

Read more →

Visibly becomes first FDA cleared online vision test in the United States

16 August 2022 - Visibly is excited to announce that, as of 12 August  2022, it has received 510(k) clearance ...

Read more →

Healthy.io receives landmark FDA clearance for first and only smartphone powered home kidney test

12 July 2022 - As first test to receive FDA clearance across all current iOS and Android smartphone devices, Minuteful ...

Read more →

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.  ...

Read more →

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) ...

Read more →

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 ...

Read more →

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.  ...

Read more →

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, ...

Read more →

Clinical decision support software

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

Read more →

Regulation of software based medical devices

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

Read more →

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 ...

Read more →

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 ...

Read more →