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: premarket submission
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
