TytoCare receives FDA 510(k) for wheeze detection software

By March 15, 2023 March 26th, 2023 News

Tyto Insights for Wheeze Detection analyzes lung sounds for possible wheezing in adults and children 2 and older.

Virtual primary care company TytoCare received FDA 510(k) clearance for clinical decision support software that analyzes lung sounds for possible wheezing.

Tyto Insights for Wheeze Detection uses TytoCare’s stethoscope to evaluate lung sounds and identify recordings that suggest wheezing in adults and children ages 2 and older. It prompts a clinician when wheezing is suspected.

The software received a European CE Mark last year.

“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.

“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.”


Founded in 2012, TytoCare provides virtual care using a connected device that allows clinicians to conduct exams remotely, including throat, ear and skin exams. According to the FDA’s database, the company has received four FDA 510(k) clearances. It received its first 510(k) green light in 2016 for its digital stethoscope.

TytoCare most recently added $50 million to its Series D raise in 2021, bringing the round to a total of $100 million. At the time, the company said it planned to use the funds to continue to expand in the U.S., Europe and Asia.

There are a number of virtual care and digital health companies that aim to offer primary care, including moves by retail and pharmacy players to expand in the space. Amazon recently closed its purchase of primary care provider One Medical, while CVS signed a deal to purchase Oak Street Health, a primary care provider geared toward the Medicare population. CVS also recently invested in primary and urgent care company Carbon Health.

Although primary care is associated with better health and improved healthcare access and experience, fewer adults had an identified primary care provider in 2015, compared with 2002.