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Digital Health Roundup: HLTH, LSX, AdvaMed; FDA And Pre-Determined Change Control Plans
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights interviews with behavioral health experts on implementing AI solutions to help ease the administrative burden on clinicians as well as recent coverage from the LSX Congress USA and HLTH conferences. Reed Miller discusses findings of EY’s annual pulse of the medtech industry report and Hannah Daniel discusses FDA guidance on regulating AI/ML.
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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.