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Tyto Insights for Eardrum Bulging Detection
Tyto Care , Ltd.
FDA-cleared AI medical device
An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.
FDA Submission Metadata
- Submission number
- DEN250014
- Decision date
- March 2026
- FDA panel
- Ear Nose & Throat
- Product code
- SHL
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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