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FDA Clears TytoCare’s New Algorithm for Wheeze Detection


Virtual care company TytoCare on Wednesday received clearance from the Food and Drug Administration for its wheeze detection algorithm, allowing the company to begin commercializing the product in the U.S.

TytoCare is headquartered in New York City and conducts research and development in Israel. The company was founded in 2012 on the belief that traditional telehealth — delivered by the likes of Amwell, Teladoc and MDLive — often leaves much to be desired. 

“The telehealth opportunity remains unfulfilled due to the inability to effectively deliver on the promise of virtual care using only chat/phone/video. Current solutions do not address the different aspects of healthcare delivery beyond just the clinical, such as user engagement and cultural aspects,” said Dedi Gilad, TytoCare’s CEO and co-founder, in a recent interview.

To remedy this problem and give patients a better option for at-home primary care, TytoCare launched its Home Smart Clinic last year.  The platform enables accessible primary care from home that is designed to replicate in-person clinician visits. It also gives providers and health plans the range of products and services needed to operate successful virtual primary care programs.

Gilad believes companies should be offering smart devices to patients to deliver on the promise of quality virtual care. That’s why his company equips patients with handheld remote medical exam devices, which allows them to perform guided medical exams at home with the virtual assistance of a healthcare provider. The company also offers patients an app and clinician dashboard, that work in real-time to provide a live image and patient data stream.

The Home Smart Clinic includes three components: TytoCare’s FDA-cleared  remote medical exam device, its suite of user engagement services and its AI-powered diagnosis support software. The diagnosis support software, named Tyto Insights, guides patients to conduct successful physical exams at home, as well as aids clinicians with AI-based diagnosis capabilities for a wide array of conditions

The new wheeze detection algorithm is an expansion of Tyto Insights, Gilad explained. He said the newly cleared algorithm will fuel further support for at-home acute care and chronic condition management by enabling clinicians to accurately diagnose respiratory conditions remotely.

The offering, called Tyto Insights for Wheeze Detection, combines AI with spectral analysis and signal processing techniques to analyze recorded lung breathing sounds. The algorithm automatically evaluates lung recordings after a patient conducts an at-home lung exam using TytoCare’s remote exam device.

If a wheeze is detected, the patient’s doctor will receive an indication. The doctor will then decide on the diagnosis in conjunction with all other relevant exams and patient data, Gilad said.

To measure the effectiveness of its wheeze detection algorithm, TytoCare performed clinical validation on a set of lung recordings that was independently assessed by both specialist pulmonologists and general practitioners.

“This enabled us to both validate the results with pulmonologists and compare our results to those of primary care physicians, which enabled us to understand that our detection capabilities are more accurate than the primary care physicians,” Gilad declared.

Photo: ThitareeSarmkasat, Getty Images



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