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
November 4, 2023
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Category: Artificial intelligence (AI)
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
August 17, 2023
Comments on FDA Draft Guidance Related to Predetermined Change Control Plan for Artificial Intelligence and Machine Learning (AI/ML) Enabled Device Software Functions
It is not often the FDA offers truly transformative guidance to enable industry to constructively advance cutting edge technology in a practical way. But with the draft FDA guidance titled “Marketing Submission Recommendations for a Predetermined Change Control…Read More
August 8, 2023
AI Enabled Medical Devices with Recent FDA De Novo or 510(k) Clearances
Medical device makers have seen a productive summer with warm receptions at FDA for Artificial intelligence (AI) enabled devices. Over the last five weeks, a number of De Novo classifications and 510(k) clearances granted by FDA cover a…Read More
September 13, 2018
Apple Watch Series 4 Gains Two FDA Regulated Medical Device Products in a Week
Apple made a number of high profile announcements yesterday regarding their new iPhone releases, but of particular interest to the medical device world was the Apple Watch Series 4 product announcement by the Verge on the incorporation of…Read More
