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# FDA Clears Telehealth Respiratory Wheeze Detector
- URL: https://www.fdaweb.com/fda-clears-telehealth-respiratory-wheeze-detector/
- Published: 2023-03-15T12:00:00.000Z
- Updated: 2026-09-14T18:19:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153992

FDA has cleared a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the company’s existing artificial intelligence (AI)-powered Tyto Insights smart diagnostic for telehealth use. Wheeze Detection is designed to “aid in the clinical assessment of lung sound data for adults and children aged two and above, enabling clinicians to accurately diagnose respiratory conditions remotely,” the company says. “Fueled by TytoCare’s own database of lung sounds – the largest of its kind – the AI-powered decision support software automatically analyzes lung sounds recorded by TytoCare’s FDA-cleared handheld remote exam device’s stethoscope to determine whether wheezing is detected.” During the exam, the device prompts a clinician if a specific abnormal lung sound suggestive of wheezing is suspected.