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How the FDA Regulates Artificial Intelligence in Healthcare — And What That Means for Patients in 2026

AI tools are increasingly used in imaging, diagnostics, and clinical decision support. Here’s how the FDA regulates artificial intelligence as medical devices, what Software as a Medical Device (SaMD) means, and what patients should know about safety, updates, and limits in 2026.

How the FDA Regulates AI in Healthcare — And What It Means for Patients

Artificial intelligence is increasingly used in imaging, heart monitoring, and disease screening. Here’s how the U.S. Food and Drug Administration regulates AI-enabled medical devices — and what that oversight means for patient safety, transparency, and trust.

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