Blog
RSS FeedPosted by Michael Wonder on 28 Sep 2022
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 ...
Posted by Michael Wonder on 12 Sep 2022
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. ...
Posted by Michael Wonder on 05 Sep 2022
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 ...
Posted by Michael Wonder on 29 Aug 2022
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. ...
Posted by Michael Wonder on 16 Aug 2022
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, ...
Posted by Michael Wonder on 08 Aug 2022
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 ...
Posted by Michael Wonder on 14 Jun 2022
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 ...
Posted by Michael Wonder on 24 May 2022
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 ...
Posted by Michael Wonder on 17 May 2022
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 ...
Posted by Michael Wonder on 16 Nov 2021
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 ...
Posted by Michael Wonder on 27 Oct 2021
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 ...
Posted by Michael Wonder on 07 Oct 2021
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. ...
Posted by Michael Wonder on 16 Aug 2021
Artificial intelligence in medicine regulation
16 August 2021 - The International Coalition of Medicines Regulatory Authorities sets out recommendations to help regulators to address the ...
Posted by Michael Wonder on 04 Aug 2021
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 ...
Posted by Michael Wonder on 21 Jun 2021
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 ...