Telehealth company TytoCare has obtained CE Mark for its artificial intelligence (AI)-backed Tyto Lung Sounds Analyzer, a web-based software system.
Developed based on TytoCare’s database of clinical exams, the new system adds additional capabilities to its existing solution.
It supports the clinical evaluation of lung auscultation sound data by analysing lung sounds recorded using the company’s off-the-shelf TytoCare Stethoscope, which has CE Mark and clearance from the US Food and Drugs Administration (FDA).
The Tyto Lung Sounds Analyzer is designed to identify the presence of abnormal breath sounds in respiratory recordings, such as wheezing in adults and children.
This can help physicians remotely diagnose respiratory conditions.
The company stated that the CE mark will allow it to immediately launch the device in Europe.
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TytoCare CEO and co-founder Dedi Gilad said: “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.
“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.”
At present, TytoCare is seeking FDA approval for the device.
Last January, the company introduced its FDA-cleared fingertip Pulse Oximeter (SpO₂) medical device for measuring blood oxygen saturation levels and heart rate remotely.