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Monday, Mar 25 2024

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FDA's Role In Medical Device Approval In Spotlight Amid AI Revolution

Artificial intelligence technology developments like those from Nvidia, Johnson & Johnson, and app-makers aiming to help the mental health crisis are in the news, as the FDA's role in approving new AI-enabled medical devices and software is discussed.

When it comes to commercializing artificial intelligence solutions, many digital health companies face a long road that runs directly through Silver Spring, Maryland. Silver Spring is the headquarters of the Food and Drug Administration, the agency providing clearances, designations and approvals for an increasing number of AI-enabled medical device and software products. (Perna, 3/22)

Last week, Nvidia announced deals with Johnson & Johnson for use of generative AI in surgery, and with GE Healthcare to improve medical imaging. The health care developments at its 2024 GTC AI conference, — which also included the launch of roughly two dozen new AI-powered, healthcare-focused tools — demonstrate just how important medicine is to Nvidia’s non-tech sector revenue opportunities in the future. (Castillo, 3/24)

Download the mental health chatbot Earkick and you’re greeted by a bandana-wearing panda who could easily fit into a kids’ cartoon. Start talking or typing about anxiety and the app generates the kind of comforting, sympathetic statements therapists are trained to deliver. The panda might then suggest a guided breathing exercise, ways to reframe negative thoughts or stress-management tips. It’s all part of a well-established approach used by therapists, but please don’t call it therapy, says Earkick co-founder Karin Andrea Stephan. (Perrone, 3/23)

Doctors using new artificial intelligence tools to help them diagnose and treat their patients say they wish Congress would provide some clarity on a big unanswered question: Who pays if AI makes a mistake? Advancements in AI promise to improve care, but only if doctors trust the systems and are protected from liability, according to the country’s leading physicians’ group, the American Medical Association. (Payne, 3/24)

The health care sector is a notorious laggard when it comes to technology. It was slow to use computers, digitize patient data, and share information electronically. While most of the world instantly interacts via Zoom and Slack, hospitals — even today — are still sending faxes. But something different is happening with generative AI. (Ross, 3/25)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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