Assurance labs, a potentially key part of the development of artificial intelligence for medtech industy use, are not part of the official regulatory process yet, which could raise questions for the US Food and Drug Administration as the technology pushes further into the industry.
AI Assurance Lab Concept Leaves Potential Regulatory Gap
In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.
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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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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.
23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.
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With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.
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The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.
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With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.