Lexology September 19, 2025
The U.S. Food and Drug Administration (FDA) has issued two significant warning letters in recent months—one to SeniorLife Technologies Inc. and another to Whoop—that together mark a clear escalation in the agency’s enforcement posture toward AI-enabled health software. These actions underscore FDA’s commitment to ensuring that consumer-facing digital health tools being marketed with diagnostic functionality adhere to essential regulatory standards.
SeniorLife.AI: Diagnostic AI marketed without clearance or controls
In its August 21, 2025 warning letter, FDA cited SeniorLife Technologies Inc. for marketing its SeniorLife.AI mobile application without proper premarket authorization and in violation of multiple provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). The app uses artificial intelligence to assess mobility and cognitive health, including fall risk prediction...
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