TytoCare Completes AI Lung Sound Suite with Latest FDA Clearance For Rhonchi, A World’s First
Tyto InsightsTM for Lung Sounds now the first in the world to receive FDA clearance for AI-based detection of all three major abnormal lung sounds: wheezes, crackles, and rhonchi, setting a new standard in virtual respiratory care.
New York, NY, April 15, 2025 –TytoCare, a virtual care company enabling accessible, high-quality primary care from home, is the first company in the world to receive FDA clearance for AI-based detection of all three major abnormal lung sounds. The company announced today the completion of its AI-powered lung sound suite with the FDA clearance of Tyto Insights™ for Rhonchi Detection. With this latest clearance, TytoCare’s platform now offers comprehensive, AI-driven analysis of the three most clinically significant abnormal lung sounds—wheezes, crackles, and rhonchi—directly within its Home Smart Clinic and Pro Smart Clinic solutions. The diagnosis of these abnormal lung sounds presents a recognized challenge for trained medical professionals, as noted in the FDA clearance, underscoring the significance of this advancement as a major milestone in the evolution of virtual care.
This milestone marks a major leap forward in TytoCare’s mission to transform virtual respiratory care. By combining smart digital stethoscope technology with AI that identifies key lung sound abnormalities, TytoCare enables providers to deliver faster, more accurate diagnoses, while patients will get timely, high-quality care from the comfort of their homes, reducing unnecessary clinic visits and improving health outcomes through earlier detection and intervention.
“Completing our AI lung sound suite is a turning point for virtual care,” said Dedi Gilad, CEO and Co-Founder of TytoCare. “Wheezes, crackles, and rhonchi are critical markers in diagnosing respiratory conditions, and now our AI assists clinicians in detecting all three using TytoCare during a virtual exam. This enhances decision-making and ensures that patients receive the right care at the right time.”
Tyto InsightsTM for Lung Sounds is built on TytoCare’s proprietary database of 1.8 million lung sound recordings and leverages machine-learning algorithms trained and validated by pulmonologists. Each component of the suite—wheeze detection (FDA-cleared in 2023), crackle detection (FDA-cleared in 2024), and now rhonchi detection—analyzes lung acoustic signals in real-time and flags potential abnormalities for clinical review. The Rhonchi device was cleared as an Rx device, and for the end user as well.
Clinical validation demonstrated that the device performs equivalently to, or better than, non-pulmonologist clinicians — confirming that the algorithm is a powerful and reliable detector of rhonchi. The performance and accuracy of the Tyto Insights software for detecting wheeze, crackles, and rhonchi were evaluated using retrospective validation datasets sourced from real-world use of the FDA-cleared compatible Tyto Stethoscope.
The algorithm demonstrated strong discriminative ability across all three sound types, as measured by the area under the receiver operating characteristic curve (AUC). The algorithm’s AUC was 95.85%, compared to 79.45% for general practitioners and 83.03% for experts. While multiple performance indicators were assessed, the statistics reported above refer specifically to AUC values—an overall performance measure that evaluates both positive and negative detections and reflects the level of confidence clinicians have in the results.
Lung sound analysis is a core element of TytoCare’s Home and Pro Smart Clinics, which replicate the in-person clinical experience virtually and support exams of the heart, lungs, throat, ears, and skin. Respiratory conditions account for more than 40% of diagnoses made using TytoCare’s platform, underscoring the importance of intelligent respiratory diagnostics in home-based care, while Rhonchi is associated with bronchitis and COPD.
About TytoCare
TytoCare 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 five times higher than traditional telehealth services; reduces the total cost of care by an average of five percent; diverts ED visits by an average of 10.8 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.
For further information, please contact:
Mira Marcus | TytoCare PR | mira.marcus@tytocare.com
