FDA Clears AI Tool for Lung Sound Detection in Clinics and Homes

The US food and Drug Administration (FDA) has cleared TytoCare's AI-powered device, Tyto Insights for Lung Sounds, to detect rhonchi, adding to its existing capabilities for identifying wheeze and crackles. Designed for use in primary care settings and patient homes, the tool brings specialist-level lung sound detection to more accessible environments.

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.