TytoCare this week received CE mark approval for its Tyto Lung Sounds Analyzer for remote medical exams.
The New York-based company designed the AI-powered Tyto Lung as a web-based software module that adds more capabilities to the existing TytoCare portfolio. It processes recordings from the company’s off-the-shelf compatible electronic TytoCare stethoscope and aids in the clinical assessment of lung auscultation sound data by analyzing recorded lung sounds to detect wheezing in adults in children.
TytoCare said that the CE mark approval will allow it to immediately launch in Europe. It is currently seeking FDA clearance.
“Receiving the CE mark on the Lung Sounds Analyzer is an important milestone for TytoCare, as it brings to market a powerful, highly integrated, and easy-to-use software system that will benefit both healthcare providers and patients,” CEO Dedi Gilad said in a news release. “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. In addition, this approval is a crucial step in our support of our European partners in their goal of transforming primary care delivery.”