Beginning on 1 October 2023, the Food and Drug Administration will refuse to accept premarket submissions that do not include information from the cybersecurity amendments of the Food, Drug and Cosmetic Act.
‘Refuse to Accept’ Decisions For Cyber Devices To Begin In October
The US FDA is giving sponsors a grace period of six months before it will issue “refuse to accept” decisions for premarket submissions for cyber devices that lack the information required under recent cyber amendments.
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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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ModMed unveiled its AI-powered ambient listening and clinical documentation software for orthopedic clinics at AAOS, ahead of its planned late-summer release. The health care software provider aims to create “the AI-powered practice” for specialty clinics to reduce clinicians' administrative burden and streamline clinical workflows.
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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.
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.