Through the De Novo process, TytoCare has established a first-of-its-kind classification for an “ear, nose, and throat image analyzer,” a new regulatory category. The company has added a new layer to its solution, which uses AI to analyze otoscopy video recordings of the eardrum to aid healthcare providers and patients by detecting eardrum bulging, which is a common sign in Acute Otitis Media and other conditions.

Tyto Insights™ for ENT Suite is designed to automatically detect bulging of the eardrum in otoscopic video recordings captured using TytoCare’s compatible digital otoscope. The solution is intended for patients aged six months and older and provides results to healthcare providers as a clinical support tool, and informs patients about their condition. TytoCare’s proprietary database of 1.6 million ear images and recordings enabled the development of Tyto Insights™ for ENT Suite.