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The AI-driven software analyzes otoscopy videos to detect eardrum bulging, establishing a new regulatory category for ENT diagnostic aids. TytoCare has received FDA De Novo classification for its Tyto Insights for ENT Suite, an artificial intelligence-powered solution for analyzing otoscopy videos. The classification establishes a new regulatory category for an “ear, nose, and throat image analyzer.” The software is designed to automatically detect bulging of the eardrum in video recordings captured with TytoCare’s compatible digital otoscope. It is intended for use in patients aged six months and older, providing results to healthcare providers as a clinical support tool and to inform patients about their condition. The detection of eardrum bulging is a common indicator in conditions such as acute otitis media. According to the company, the AI model was developed using a proprietary database of 1.6 million ear images and recordings. The combination of a connected otoscope with AI analysis is intended to enable consistent identification of eardrum bulging, which can be challenging to assess through standard telehealth solutions. The company suggests that more accurate detection may lead to a reduction in unnecessary antibiotic use and fewer delays in treatment. Ear-related conditions account for approximately 20 million doctor visits annually in the US, making them one of the most common reasons for pediatric appointments. “This is not just a product milestone, it is a regulatory breakthrough,” says Elad Lachmanovich, chief technology and product of TytoCare, in a release. “We are building an AI layer for primary care that can interpret clinical-grade data from the home and turn it into actionable insight. This De Novo establishes the foundation for a new generation of AI-driven diagnostics, where software continuously learns from multimodal data to guide care, triage patients, and support clinical decisions at scale.” The ENT Suite is part of TytoCare’s portfolio of AI-powered decision support tools. The company’s Home Smart Clinic and Pro Smart Clinic solutions enable remote examinations of the heart, lungs, throat, ears, and skin to support remote diagnosis and treatment. Featured image: Left: healthy eardrum. Right: bulging eardrum. TytoCare's FDA De Novo-classified Al automatically detects eardrum bulging in otoscopic video recordings captured with TytoCare's compatible digital otoscope. Photos: TytoCare

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FDA Grants De Novo Classification to TytoCare’s AI Otoscopy Tool

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