1 device · 1 company · 2026
AI-enabled ear nose & throat devices on FDA's list
1 device in the Ear Nose & Throat panel, 2026, from 1 company across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Tyto Insights for Eardrum Bulging DetectionDEN250014 · De Novo | Tyto Care , Ltd. | SHL | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.