Virtual care company TytoCare has received FDA 510(k) clearance for its wheeze detection algorithm, which will allow the company to begin commercialisation in the U.S. The software had previously received a European CE mark.
The Tyto Insights for Wheeze Detection uses TytoCare's stethoscope to evaluate lung function in adults or children over 2 years old. The new device combines AI with spectral analysis and signal processing techniques to analyse recorded lung breathing sounds. The algorithm then automatically evaluates the lung recordings using TytoCare’s remote exam device. If a wheeze is detected the patient's physician will receive a notification and decide on a diagnosis based on this information, combined with patient history and other data.
"Our Tyto Insight capabilities, including our wheeze detection algorithm, furthers our goal of enhancing the virtual care experience for all patients, clinicians, providers and health plans – not just by increasing the quality of care and expanding our chronic care management capabilities, but also by further assisting clinicians and specialists to make informed and accurate diagnoses remotely," Dedi Gilad, CEO and cofounder of TytoCare, said in a statement.
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