Digital stethoscope maker Tyto Care nabs European approval for its lung sound-identifying AI

Tyto Care has received a European approval for an artificial-intelligence-powered add-on to its digital stethoscope system, allowing the device to identify certain lung sounds such as wheezing and assist clinicians in remotely diagnosing respiratory conditions.

The CE mark covers the web-based software module as a separate medical device. It is designed to analyze lung sounds recorded by the company’s off-the-shelf TytoCare Stethoscope, which also has a CE mark and clearance from the FDA.

The telehealth system is part of a handheld, primary care exam kit that allows users to inspect the lungs, heart, skin, ears, throat and abdomen while also measuring pulse rate, body temperature and blood oxygen levels.

“We are confident that this will enhance telehealth usage in the European market and will help deliver improved outcomes in detecting wheezes and in the future other respiratory abnormalities,” TytoCare co-founder and CEO Dedi Gilad said in a statement.

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