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Reported The Amplifier Cringe
FDA warns Exer Labs over AI “screen, diagnose, and treat” claims for Exer Scan
On 10 February 2025, the U.S. Food and Drug Administration issued a warning letter to Exer Labs, Inc. (Denver, CO) after an inspection of the firm from 17–24 October 2024. FDA determined that the firm’s Exer Scan product is a device under section 201(h) of the FD&C Act. The letter states that Exer Scan is adulterated for lack of an approved PMA or IDE for the device as described and marketed, and misbranded for failure to submit a required 510(k) premarket notification. ([warning letter](http...
An AI/computer-vision product listed under an exercise-equipment exemption was marketed with disease screening, diagnosis, and treatment framing that FDA said exceeded that exemption — amplifying clinical authority without the premarket and quality-system constraints those intended uses imply.
On 10 February 2025, the U.S. Food and Drug Administration issued a warning letter to Exer Labs, Inc. (Denver, CO) after an inspection of the firm from 17–24 October 2024. FDA determined that the firm’s Exer Scan product is a device under section 201(h) of the FD&C Act. The letter states that Exer Scan is adulterated for lack of an approved PMA or IDE for the device as described and marketed, and misbranded for failure to submit a required 510(k) premarket notification. (warning letter)
FDA reviewed Exer Labs’ website and cited marketing that went beyond the measuring-exercise-equipment exemption (21 CFR 890.5360), including claims about using clinical AI / computer vision to screen, diagnose, and treat musculoskeletal and neurological disorders — for example, screening and treating patients with Parkinson’s, TB, and cerebral palsy, and senior-care framing around screening and treating patients to prevent falls. The agency also cited Quality System regulation gaps, including failures to adequately establish procedures for design controls, complaint evaluation, CAPA, purchasing controls, management review, quality audits, and training. FDA requested that the firm cease activities that result in misbranding or adulteration of Exer Scan for the uses discussed in the letter. A warning letter is an enforcement communication, not a court judgment. (warning letter)