I see a lot of 510(k)s and de novos in the course of my work, so it is always inspiring to see something truly groundbreaking make it through the FDA. The recent de novo from Cardiosense announced last week…Read More
June 5, 2026
Contact Us
News
Category: Artificial intelligence (AI)
May 22, 2026
The Hunt for the Next FDA Commissioner
It is last weeks news that FDA’s leadership turnover has been the highest in memory, possibly ever. What should concern everyone is the response of industry to this degree of uncertainty at FDA. Drug company Regenxbio last week…Read More
March 12, 2026
FDA holds virtual Town Hall meeting on Clinical Decision Support guidance update
The FDA held a virtual town hall on March 11th, 2026 on the Clinical Decision Support (CDS) Software guidance update, which published on January 6th, 2026 and republished on January 29, 2026. This was an eagerly awaited event to…Read More
January 7, 2026
FDA releases update to Clinical Decision Support Software guidance that expands non–regulated opportunities for AI industry
The FDA released an update to the Clinical Decision Support Software (CDS software) guidance yesterday (January 6, 2026) in what was a surprise move to virtually all in the FDA regulatory space. To put some historical context on…Read More
January 6, 2026
FDA releases update to General Wellness guidance that creates new opportunities for industry to operate without FDA regulation
The FDA released a final guidance update to the General Wellness: Policy for Low Risk Devices today (January 6, 2026) in what could only be characterized as a sudden and momentous event. It is worth noting that this…Read More
December 18, 2025
Proposed amendment to EU MDR could relax rules on AI medical device software
There was recent news for the possible relaxation of rules for MDR with respect to medical device software (MDSW), including for MDSW utilizing artificial intelligence (AI). The December 16, 2025 proposed amendment to classification rules for MDSW for…Read More
December 9, 2025
Industry players request that FDA Center for Devices and Radiological Health (CDRH) withdraw certain guidances and prioritize other guidances in fiscal year 2026
The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances…Read More
November 4, 2023
FDA Warning Letter Issued for Non-Validated AI Code Claimed “For Research Use Only”
FDA recently issued a warning letter to Wavi that claimed its AI code used for its Wavi Desktop product was “for research use only” and not subject to FDA regulation. This is not a judgement on Wavi as…Read More
October 19, 2023
CDRH Proposed Guidances for Fiscal Year 2024 Related to Artificial Intelligence/Machine Learning (AI/ML) Enabled Device Software Functions
It is encouraging to see the FDA’s Center for Devices and Radiological Health (CDRH) has signaled in their proposed guidances for fiscal year 2024 (FY2024) that guidances related to Artificial Intelligence/Machine Learning (AI/ML) are getting a high priority…Read More
August 24, 2023
Follow-up On AI Enabled Medical Devices with Recent De Novo Classifications
Two devices with recent De Novo Classifications were reported on recently in the Viz.ai HCM and Better Therapeutics devices that employ Artificial Intelligence (AI) and/or Machine Learning (ML). The Classification Order for both were recently published and present…Read More
