Tuesday, December 2, 2025

FDA Introduces “Agentic AI” to Enhance Pre-Market Reviews and Staff Efficiency

Mario Aguilar reports on the transformative role of technology in healthcare, covering topics like artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His insights delve into how these innovations are reshaping healthcare practices while also addressing the related business and policy challenges. Aguilar co-authors the STAT Health Tech newsletter, providing timely updates on healthcare technology. Recent FDA announcements highlight the introduction of advanced artificial intelligence tools aimed at enhancing pre-market reviews and other functions, despite concerns around AI’s unpredictability. The FDA emphasizes that these “agentic AI capabilities” will assist staff in various operational tasks, while strict guidelines ensure that human oversight remains integral to decision-making processes. As the FDA adapts to the evolving tech landscape, maintaining a balance between innovation and regulatory integrity is crucial, especially amid workforce reductions impacting the agency. For deeper insights, subscribe to STAT+.

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