The US Food and Drug Administration (FDA) has granted 510(k) clearance for TytoCare’s Tyto Insights for Wheeze Detection, designed to aid in the clinical assessment of lung sound data for adults and children aged 2 and older, enabling clinicians to diagnose respiratory conditions remotely.
The 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. Whenever a remote lung exam is carried out, Tyto Insights for Wheeze Detection prompts a clinician if a specific abnormal lung sound suggestive of wheezing is suspected.
The FDA clearance paves the way for TytoCare’s rollout in the US and strengthens its offerings for virtual primary care from home with its Home Smart Clinic, according to a press release by the company. Tyto Insights for Wheeze Detection bolsters the Home Smart Clinic’s support of acute care and long-term care for chronic conditions, many of which are respiratory in nature.
To date, TytoCare has found that respiratory diagnoses constitute over 40% of all diagnoses made using its virtual care solution, reflecting both the common nature of respiratory illnesses and conditions including asthma across patient populations.
“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,” says Dedi Gilad, CEO and co-founder of TytoCare, in a press release.
The Tyto Insights for Wheeze Detection already bears the CE Mark for usage by clinicians in Europe.
Photo credit: TytoCare