FDA-Cleared AI Lung Sound Tool Extends Specialist Diagnostics to Primary Care, Home

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TytoCare has received FDA clearance for the latest addition to its AI-driven lung sound detection suite, Tyto Insights™ for Rhonchi Detection. This marks the first time a platform has received FDA approval for AI-based detection of all 3 major abnormal lung sounds—wheezes, crackles, and rhonchi, according to a press release.¹

“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,” Dedi Gilad, chief executive officer and cofounder of TytoCare, said in the press release.¹

The addition of rhonchi detection builds on previously FDA-cleared features for wheeze and crackle detection, which were approved in 2023 and 2024, respectively.^2,3 Designed for use in both primary care clinics and patient homes, the AI algorithm behind Tyto Insights for Lung Sounds presents physicians and patients with a specialist’s/pulmonologist’s second opinion and allows for earlier diagnosis and treatment.¹

The TytoCare system uses machine learning algorithms trained on a proprietary database of 1.8 million lung sound recordings to analyze lung acoustic signals in real time. The AI system flags potential abnormalities for clinical review, enhancing the clinician’s ability to make accurate diagnoses during virtual exams. According to clinical validation studies, TytoCare’s AI algorithm demonstrated an area under the receiver operating characteristic curve (AUC) of 95.85% for detecting wheezes, crackles, and rhonchi—substantially outperforming general practitioners (79.45% AUC) and pulmonary experts (83.03% AUC).¹

This development is significant for the growing field of virtual care, particularly in the management of respiratory conditions. Respiratory diagnoses account for over 40% of the cases seen through TytoCare’s platform, emphasizing the importance of accurate and timely diagnostic tools. With the addition of rhonchi detection, clinicians can now use the system to detect all major abnormal lung sounds, facilitating more comprehensive virtual assessments.¹

Rhonchi, which is often associated with conditions such as bronchitis and chronic obstructive pulmonary disease, can be challenging to detect accurately, particularly in nonspecialist settings. By incorporating AI-based analysis into virtual exams, TytoCare’s platform enables health care professionals to identify these sounds with greater precision, supporting earlier intervention and reducing the need for in-person visits.¹

References:

1. TytoCare Completes AI Lung Sound Suite with Latest FDA Clearance For Rhonchi, A World’s First. News release. TytoCare. April 15, 2025. Accessed April 29, 2025. https://www.tytocare.com/press-releases/tytocare-completes-ai-lung-sound-suite-with-latest-fda-clearance-for-rhonchi-a-worlds-first/

2. TytoCare Receives FDA Clearance for its AI-Powered Tyto Insights™ for Wheeze Detection to Ensure Diagnostic Accuracy from Home. News release. TytoCare. March 15, 2023. Accessed April 29, 2025. https://www.tytocare.com/press-releases/tytocare-receives-fda-clearance-for-its-ai-powered/

3. TytoCare Receives FDA Clearance for AI Lung Crackle Detection. News release. TytoCare. July 30, 2024. Accessed April 29, 2025. https://www.tytocare.com/press-releases/tytocare-receives-fda-clearance-for-ai-lung-crackle-detection/