# HD-INC-174: The FDA told a company its AI app was an unapproved medical device after it advertised a five minute gaze test to detect early signs of Alzheimer's disease > The United States Food and Drug Administration inspected SeniorLife Technologies, Inc. from 24 to 26 March 2025 and issued a warning letter on 21 August 2025. The letter quotes promotional statements including that a Cognitive Health Agent conducts a five minute gaze based test on an iPad to detect early signs of Alzheimer's, that a Mobility Health Agent proactively identifies fall risk and recommends interventions, that the company's AI enabled computer vision software can assist a caregiver to perform tests that provide a quick pre-diagnosis, and that the product was proven to reduce falls by 58 per cent in a two year Japanese study. The agency found these claims made the app a device intended for use in the diagnosis of disease, that the firm had listed it under the classification for measuring exercise equipment at 21 CFR 890.5360, and that its intended use fell outside that classification. The letter records that the device was adulterated for want of premarket approval and misbranded, that the website's FDA Approved representation is false and its FDA Certified statement both false and misleading, and that the firm had not performed a quality audit since it was established in 2022. - Source: https://useheadlights.com/library/HD-INC-174/ - Publisher: Headlights (useheadlights.com), author Ellie Harris - Published: 2026-08-29 - Company: SeniorLife Technologies, Inc. - Sector: Digital health - Country: United States - Year: 2025 - Behaviour in the record (Headlights reading): Overconfidence; also Rules-behaviour gap - Governance domains: Marketing alignment, Consumer protection, Algorithmic accountability - Licence: CC BY-NC 4.0. Cite as: Harris, E. (2026). The FDA told a company its AI app was an unapproved medical device after it advertised a five minute gaze test to detect early signs of Alzheimer's disease. Headlights AI Incident Library, HD-INC-174. https://useheadlights.com/library/HD-INC-174/ ## What happened It was reported that the United States Food and Drug Administration issued a warning letter on 21 August 2025 to a company whose mobile application used artificial intelligence to assess older adults. The letter quotes statements used to promote the product. They included that it conducts a five minute gaze based test on an iPad to detect early signs of Alzheimer's, that it proactively identifies fall risk and recommends interventions, and that it was proven to reduce falls by 58 per cent in a two year Japanese study. It was reported that the agency found the app was being promoted for uses that included screening and diagnosing disease, putting it outside the exercise equipment classification under which it had been registered. The letter states that the device was adulterated for want of premarket approval, that the website's FDA Approved representation is false and its FDA Certified statement both false and misleading, and that no quality audit had been performed since the firm was established in 2022. ## What an auditable version would have shown The FDA letter says the claims appeared on the company's website and app store listings. The sources reviewed do not show how many people used the product, how many were told they showed early signs of Alzheimer's, or what happened afterwards. The letter quotes the claim that falls were reduced by 58 per cent in a two year Japanese study, but does not identify that study. The company could have kept a record showing what evidence supported each health claim, what regulatory status the product held at the time and who approved the claim. For each assessment, it could also record what went into the model and what result was given to the carer. ## Where the gap was The FDA says the product was represented as FDA Approved even though it had not received premarket approval. It also says FDA Certified was false and misleading because the FDA had not certified the device. A ConstraintGate is designed to check whether the organisation holds the authorisation behind a claim before it is published. A VerificationGate checks claims such as the 58 per cent figure against the evidence supporting them. A ConductRecord keeps a record of the claim, the evidence and what those checks found. ## What governance should have looked like The FDA found that the product had been registered under 21 CFR 890.5360 for Measuring Exercise Equipment, but that its promoted AI screening and diagnostic uses fell outside that classification. The letter also says the product had not received the required premarket approval. Where an organisation makes health claims about an AI product, best practice would be to check those claims against the product's actual regulatory status before publishing them. It should also hold the evidence behind any effectiveness claim and keep a record of who approved it. **Failure Pattern:** the product was promoted as detecting early signs of Alzheimer's and claimed a 58 per cent reduction in falls from a study that was not identified in the FDA letter. The FDA found that the product's promoted uses fell outside the classification under which it had been registered. **Governance Principle:** before making a health claim about an AI product, an organisation should be able to show the evidence behind the claim and that the product has the regulatory status the claim requires. The reference implementation of ConstraintGate, VerificationGate and ConductRecord is open source. It lives at [github.com/saffronandindia/headlights-oss](https://github.com/saffronandindia/headlights-oss), Apache 2.0 licensed and free to install. The repository is public now. ## Sources - [Warning letter to SeniorLife Technologies, Inc., reference 707021 (US Food and Drug Administration, 21 August 2025)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seniorlife-technologies-inc-707021-08212025) - [The company's own website, reviewed August 2026](https://seniorlife.ai/) - [FDA enforcement against SeniorLife and Whoop signals a new line in the sand for AI health apps (Hogan Lovells, 2025)](https://www.hlc.com/en/publications/fda-enforcement-against-seniorlife-whoop-signal-new-line-in-the-sand-for-ai-health-apps) - [FDA advertising and promotion enforcement activities update (Covington and Burling, October 2025)](https://www.cov.com/en/news-and-insights/insights/2025/10/fda-advertising-and-promotion-enforcement-activities-update) ## Related - [HD-INC-158](/library/HD-INC-158) - [HD-INC-049](/library/HD-INC-049) - [HD-INC-103](/library/HD-INC-103)