FDA taps AI executive to lead digital health center

February 19, 2026 - 18:48

In a significant move underscoring the growing convergence of artificial intelligence and regulatory science, the U.S. Food and Drug Administration has named a former executive from a leading health AI company as the new director of its Center for Devices and Radiological Health’s Digital Health Center of Excellence.

This strategic appointment signals the agency's deepening commitment to navigating the rapidly evolving landscape of software-based medical technologies. The new director brings firsthand industry experience in developing and commercializing artificial intelligence and machine learning tools for healthcare, a sector the FDA is actively working to regulate with both innovation and patient safety in mind.

The Digital Health Center of Excellence plays a pivotal role in developing regulatory frameworks, policies, and standards for digital health technologies, including wearable devices, health software, and AI-driven diagnostics. Leadership with direct expertise in the AI field is expected to enhance the FDA's ability to evaluate complex algorithms and foster responsible innovation.

Experts view this hiring as a proactive step to ensure the regulatory process keeps pace with technological advancement. It aims to provide clearer pathways for companies while maintaining the FDA's gold standard for safeguarding public health in an increasingly digital world. The director will oversee critical initiatives related to cybersecurity, real-world data, and the total product lifecycle for software.