Blog
RSS FeedPosted by Michael Wonder on 30 Apr 2025
Roche granted FDA breakthrough device designation for first AI-driven companion diagnostic for non-small cell lung cancer
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
Posted by Michael Wonder on 28 Apr 2025
New position statement aims to guide the use of AI methods in health technology assessment
25 April 2025 - Canada’s Drug Agency has published a new position statement on the use of artificial intelligence methods ...
Posted by Michael Wonder on 19 Jun 2024
How AI is revolutionising drug development
17 June 2024 - In high-tech labs, workers are generating data to train AI algorithms to design better medicine, faster. But ...
Posted by Michael Wonder on 31 May 2024
FDA plans to release AI drug development guidance this year
30 May 2024 - The US FDA plans to release a draft guidance this year on the use of artificial intelligence/machine ...
Posted by Michael Wonder on 24 Jan 2024
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience
23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...
Posted by Michael Wonder on 19 Dec 2023
Artificial intelligence workplan to guide use of AI in medicines regulation
18 December 2023 - The EMA and the Heads of Medicines Agencies have published an artificial intelligence workplan to 2028, ...
Posted by Michael Wonder on 28 Sep 2023
Where medical statistics meets artificial intelligence
28 September 2023 - Challenges at the interface of medical statistics and AI are population inference versus prediction, generalisability, reproducibility and ...
Posted by Michael Wonder on 19 Jul 2023
Reflection paper on the use of artificial intelligence in the lifecycle of medicines
19 July 2023 - The EMA has published a draft reflection paper outlining the current thinking on the use of artificial ...
Posted by Michael Wonder on 12 Jun 2023
One stop shop for AI and digital regulations for health and social care launched
12 June 2023 - A new online advice service to help the NHS and wider care system adopt and make ...
Posted by Michael Wonder on 10 Apr 2023
Health care regulators’ outdated thinking will cost American ives
10 April 2023 - In a matter of months, ChatGPT has radically altered our nation’s views on artificial intelligence—uprooting old ...
Posted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 25 Feb 2023
AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data
23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to ...
Posted by Michael Wonder on 14 Feb 2023
The future of voice technologies in health care
13 February 2023 - Adam Smith believed that the division of labor is the key to growth. ...
Posted by Michael Wonder on 10 Jan 2023
Four types of bias in medical AI are running under the FDA’s radar
9 January 2023 - Although artificial intelligence is entering health care with great promise, clinical artificial intelligence tools are prone ...
Posted 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 ...