TytoCare Receives FDA Clearance for its AI-Powered Tyto Insights™ for Wheeze Detection to Ensure Diagnostic Accuracy from Home

By March 15, 2023 March 26th, 2023 News

The clearance adds AI lung sound analysis algorithms to TytoCare’s Home Smart Clinic solutions, based on the company’s database of lung sounds – the largest of its kind across the globe – to expand acute care and chronic condition management for healthcare professionals and families at home

TytoCare, a virtual care company enabling accessible, high-quality primary care from home, today announced that it received FDA clearance for its Tyto Insights for Wheeze Detection, paving the way for its rollout in the US. The wheeze detection algorithm expands the company’s existing AI-powered Tyto Insights™ smart diagnostic capabilities, filling the quality gaps currently experienced with traditional telehealth and alleviating challenges imposed by the ongoing shortage of healthcare professionals.

Tyto Insights for 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. 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. Whenever a remote lung exam is carried out with TytoCare, Tyto Insights for Wheeze Detection prompts a clinician if a specific abnormal lung sound suggestive of wheezing is suspected.

The FDA clearance comes as TytoCare is continually strengthening its offerings to provide the best possible virtual primary care from home with its Home Smart Clinic. By expanding its clinical decision support, 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, and helps to alleviate challenges posed by the ongoing healthcare professional shortage. 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, as well as TytoCare’s unique ability to provide optimal virtual care for the large numbers of patients with respiratory symptoms by offering remote auscultation.

“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,” said Dedi Gilad, CEO and Co-Founder of TytoCare. “At TytoCare, we have the world’s largest database of lung and heart sounds, as well as related symtoms and vital signs, and we will continue to leverage it to provide superb quality of care for families worldwide.”

TytoCare’s Home Smart Clinic was introduced to solve the Home Healthcare Delivery Gap™ that patients experience with traditional audio/video-only telehealth solutions. The solution combines TytoCare’s FDA-cleared handheld remote examination device, the AI-backed Tyto Insights™ smart diagnosis support, including the Wheeze Detection, and the Tyto Engagement Labs™ configured for each specific program and cohort to provide high-quality, accessible virtual care in the home and enable health plans and providers to deliver on expected ROI and drive improved health outcomes. The Tyto Insights for Wheeze Detection already bears the CE Mark for usage by clinicians in Europe.