Joint AI/ML Risk Management Guidance Brings FDA Standard To UK
A collaborative document by a US and British organizations brings FDA-approved AI/ML risk management standards to the UK.
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Experts lamented the lack of consensus standards for AI medical devices, which they said could pose harm to innovators.
Medtech Regulatory Cybersecurity Updates: Healthcare Working Group Introduced In Senate & Third-Party Cybersecurity Guidance Recognized By FDA
A bipartisan, healthcare cybersecurity working group has been launched in the Senate and the FDA now recognizes a guidance from the AAMI on cybersecurity risk management for medical devices.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.