Home » TytoCare AI Home Wheeze Detection Device gets FDA Clearance
TytoCare AI Home Wheeze Detection Device gets FDA Clearance
Devices Submissions and Approvals
TytoCare has received FDA clearance for its Tyto Insights artificial intelligence (AI) decision support software to analyze lung sound data for clinicians to diagnose respiratory conditions remotely.
Using the company’s database of lung sounds, the software automatically analyzes lung sounds recorded by the device’s handheld stethoscope and prompt a clinician if an abnormal lung sound suggestive of wheezing is suspected.
The Tyto Insights software for wheeze detection previously gained CE mark certification in Europe.