Is Tyto Insights (AI features) FDA approved or cleared?
Yes. Tyto Insights (AI features) by Tyto Care Ltd. is named in the FDA register with a 510(k) clearance, first authorised in 2023, latest decision in 2026.
At a glance
| Product | Tyto Insights (AI features) |
|---|---|
| Maker | Tyto Care Ltd. |
| Care area | Vital signs & remote monitoring |
| What it does | AI software for the TytoCare exam kit that detects wheezes, crackles and rhonchi in lung sounds and eardrum bulging in otoscope images |
| FDA | 510(k), latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | tytocare.com |
| Status | FDA verified |
| Last checked | 18 October 2026 |
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Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes