TytoCare Secures FDA De Novo for First AI-Powered Eardrum Analysis

TytoCare is the first company to receive an FDA De Novo-classified AI solution for analyzing otoscopy videos, establishing a new regulatory category in ENT diagnostic aid, with patient access enabled through its Smart Checkup capabilities

NEW YORK, April 27, 2026 /PRNewswire/ -- TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced it has received FDA De Novo classification for the first model of Tyto Insights™ for ENT Suite, marking the creation of a new regulatory category for AI-powered ENT image analysis.

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.

Ear-related conditions, including infections such as otitis media, are among the most common reasons for pediatric visits, accounting for approximately 20 million doctor visits annually in the United States. At the same time, the U.S. is facing a growing shortage of primary care physicians, putting increasing strain on access to timely care. Yet accurate assessment of the eardrum can be challenging via standard telehealth solutions. By combining TytoCare's connected otoscope with AI-driven analysis, Tyto Insights™ enables consistent identification of eardrum bulging. Accurate detection of eardrum bulging allows for less unnecessary antibiotic usage and reductions in delayed treatment.

In parallel, TytoCare is enhancing its Smart Clinic Companion with new Smart Checkup capabilities, empowering patients with insights about their lung and ear exams, leveraging Tyto Insights™ Lung Suite and ENT Suite. The Smart Checkup is designed to support patients with deeper understanding and more informed decision-making, and increase engagement with their clinicians and their healthcare journey.

This latest milestone builds on TytoCare's growing portfolio of AI-powered decision support tools across multiple exam types, further advancing its mission to bring comprehensive, high-quality care into the home. Through its Home Smart Clinic and Pro Smart Clinic solutions, TytoCare enables remote examinations of the heart, lungs, throat, ears, and skin, helping providers deliver accurate diagnoses and treatment decisions without requiring in-person visits.

"This is not just a product milestone, it is a regulatory breakthrough," said Elad Lachmanovich, Chief Technology and Product of TytoCare. "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."

Link to high resolution image of TytoCare ear exam: 

https://drive.google.com/file/d/1iNsbvUZOCfDk2WJT50aOUl76EgDP2Xlv/view?usp=sharing

About TytoCare   

TytoCare, recently named one of the Top HealthTech Companies by TIME and included in the 2025 Best Inventions List by TIME, is a virtual healthcare company that enables leading health plans and providers to deliver remote healthcare to the whole family through its Home Smart Clinic. With a cutting-edge, easy-to-use, FDA-cleared device with embedded AI, the Home Smart Clinic enables the whole family to conduct remote physical exams with a doctor, replicating in-clinic exams for immediate answers from home. TytoCare drives utilization rates that are six times higher than traditional telehealth services; reduces the total cost of care by an average of 8.5 percent; diverts ED visits by an average of 11.3 percent; and has a high average NPS of 83. The Home Smart Clinic includes Tyto Engagement Labs™, a proven framework of engagement journeys designed for the successful deployment and adoption of the solution. To complete its offering, TytoCare also provides the Pro Smart Clinic, for professional settings outside the home to serve rural clinics, schools, workplaces, and more. TytoCare serves over 250 major health systems and health plans in the U.S., Europe, Asia, Latin America, and the Middle East.    

SOURCE TytoCare