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BioWorld - Sunday, April 5, 2026
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Product liability and medical devices

AI presents potential for new theories of medical product liability

Aug. 26, 2024
By Mark McCarty
Product liability is always a point of concern for manufacturers of medical devices and other U.S. FDA-regulated products, and the broad contours of product liability jurisprudence are well known by corporate counsel. However, artificial intelligence products are rapidly pressing their way into routine clinical use, representing a technological shift that may occasionally deviate from the existing rules of the road where product liability is concerned.
Medical technology Regulatory Artificial intelligence Digital health Artificial intelligence U.S. FDA

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