Pre-determined change control plans (PCCPs) are still in their early development stages, MiRa Jacobs, division director of digital health policy at the FDA’s Digital Health Center of Excellence (DHCOE), said during a recent panel discussion on device AI.
PCCPs, International Harmonization, Nutrition Labels And More AI Updates From FDLI
AI regulation experts discussed the pros and cons of AI “nutrition labels” for transparency, international harmonization of AI regulation and – of course—PCCPs at a recent summit.
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Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
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Early diagnosis can be “detrimental” to patients, Suzanne O'Sullivan, neurologist and author of “The Age of Diagnosis,” argued at the Wired Health conference on 18 March. "You save one life from screening 2,000 women for breast cancer, but you also treat 10 women unnecessarily," she said.
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Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.