AI-Powered Wheeze Detector Receives FDA Clearance

FDA clearance for the Tyto Insights Wheeze Detection is paving the way for its rollout in the USA.

Image credit: TytoCare

TytoCare, a virtual care company enabling accessible, high-quality primary care from home, 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, states a press release.

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.

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"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 symptoms 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 TytoInsights™ smart diagnosis support, including the Wheeze Detection, and the TytoEngagement 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.

About TytoCare

TytoCare is a virtual care company working with leading health plans and providers to roll out the Home Smart Clinic, an offering that enables accessible, high-quality primary care from home, with no compromises. The Home Smart Clinic solutions include remote physical exams that work across primary care modalities and can be tailored to any cohort or population. Together with AI-powered guidance, provider integrations, and member journeys and engagement frameworks, the Home Smart Clinic solutions ensure more equitable access to care across the globe and enable healthcare organizations to meet their KPIs. TytoCare's solutions resolve 59% more conditions than audio and video telehealth solutions and reduce the cost of care by an average of 10%. Co-founded by Dedi Gilad and Ofer Tzadik in 2012,T ytoCare has FDA and CE clearances and partners with over 220 major health systems, health plans, and strategic partners in the U.S., Europe, Asia, Latin America, and Israel.

Sam Draper
April 11, 2023

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