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 →

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 →

Collaboration arrangement between the Department of Health and Aged Care and Health Technology Assessment bodies in the United Kingdom and Canada

5 September 2022 - The Department of Health and Aged Care has signed an international collaboration arrangement with five like minded ...

Read more →

Amazon versus Apple: only one will rewrite the rules of health care

29 August 2022 - Big tech has had a surprisingly small impact on U.S. healthcare, so far. ...

Read more →

Artificial intelligence was supposed to transform health care. It hasn’t.

15 August 2022 - Machine learning could improve medicine by analysing data to improve diagnoses and target cures, but technological, bureaucratic, ...

Read more →

Bot Image receives FDA clearance for artificial intelligence software used in detection and diagnosis of prostate cancer

8 August 2022 - Bot Image has developed an AI driven medical device CAD software to significantly improve the accuracy and ...

Read more →

FDA should step in to help spur AI/ML standards

13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...

Read more →

FDA grants breakthrough device designation to Anumana’s ECG pulmonary hypertension early detection AI algorithm

24 May 2022 - Anumana today announced that the U.S. FDA has granted breakthrough device designation to its AI-enhanced, ECG based ...

Read more →

Dental AI start-up wins second FDA clearance to detect top oral diseases

16 May 2022 - The FDA has awarded dental AI start-up Overjet with landmark clearance to use its software to ...

Read more →

FDA authorises marketing of virtual reality system for chronic pain reduction

16 November 2021 - The U.S. FDA today authorized marketing of EaseVRx, a prescription-use immersive virtual reality system that uses cognitive ...

Read more →

FDA collaborates with Health Canada and UK’s MHRA to foster good machine learning practice

27 October 2021 - Today, the U.S. FDA, Health Canada and the United Kingdom’s MHRA jointly issued the “Good Machine Learning ...

Read more →

The FDA should better regulate medical algorithms

7 October 2021 - Most do not require the agency’s approval, and those that do often don’t require clinical trials. ...

Read more →

Artificial intelligence in medicine regulation

16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...

Read more →

Abbott receives FDA clearance for its imaging technology using artificial intelligence for vessels in the heart

3 August 2021 - Ultreon 1.0 software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using ...

Read more →

Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire

21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...

Read more →