Other
Tyto Insights for Eardrum Bulging Detection
Tyto Care, Ltd.
FDA
FDA-cleared AI medical device
Software that analyzes otoscopy video recordings of the eardrum to detect eardrum bulging, a common sign of acute otitis media, providing results to healthcare providers as a clinical-support aid for patients aged six months and older.
FDA Submission Metadata
- Submission number
- DEN250014
- Decision date
- March 2026
- FDA panel
- Ear Nose & Throat
- Product code
- SHL
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA
Tyto Insights for Eardrum Bulging Detection — De Novo authorization (product code SHL)
DEN250014
Class II