AI & Regulation: AdvaMed Aims To Mold Artificial Intelligence Policy For Device Industry
As AI becomes more prevalent in the medical device arena, thought-leaders in industry and US FDA are looking down the road at how artificial intelligence can be regulated in a way that doesn't stymie innovation. AdvaMed is helping to lead the charge by crafting policy points to address the issue.
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The likes of Apple, Samsung and FitBit join traditional medtech players Johnson & Johnson and Roche, along with digital-health startups in a new US FDA pilot program intended to define best-practice software design as a means to "pre-certify" companies and reduce pre-market requirements. FDA's Bakul Patel and the CEO of one pilot participant, Pear Therapeutics, weighs in.
US Regulatory Roundup, February 2021: QA/RA Predictions, FDA Warning Letter Stats, PMA Case Study, And More
Quality and regulatory predictions for 2021, a count of 2020 US FDA enforcement missives, a premarket approval case study for a novel prosthetic, and more topped our list of most-read Medtech Insight articles in February.
The recall of the kit, which is part of the HeartWare HVAD System, was affixed with the US agency’s highest risk classification on 1 March.