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FDA Relaxes Clinical Decision Support and General Wellness Guidance: What It Means for Generative AI and Consumer Wearables
In January 2026, FDA issued major updates to its Clinical Decision Support and General Wellness guidance, signaling a more innovation-friendly approach to generative AI, clinical copilots, and consumer wearables. This post explains what changed, which AI tools can now remain outside FDA regulation, and how digital health companies can design for compliance while accelerating time to market.
FDA Cracks Down on Wearable Devices: Lessons from WHOOP and Dexcom Enforcement Actions
Recent FDA actions against WHOOP and Dexcom reveal how wearables and SaMD are being regulated more aggressively. Here’s what digital health founders must know.