Israeli company TytoCare has received CE Mark approval for its AI-backed Tyto Lung Sounds Analyzer, which will help physicians better diagnose respiratory conditions remotely.
The web-based software system is designed to analyze recorded lung sounds to determine whether wheezing is detected, helping the clinical assessment of lung auscultation sound data. Auscultation is listening to sounds made by internal organs, usually with a stethoscope.
The CE Mark creates the opportunity for an immediate European rollout of TytoCare’s Lung Sounds Analyzer Software and the FDA-cleared, off-the-shelf, compatible electronic TytoCare Stethoscope. The company is currently in the process of seeking FDA clearance for the analyzer software.
“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,” according to TytoCare CEO and co-founder Dedi Gilad.
“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," he said. "In addition, this approval is a crucial step in our support of our European partners in their goal of transforming primary care delivery.”
TytoCare worked with experienced pulmonologists and general practitioners to develop the analyzer as well as use its massive database of clinical exams.
The company's algorithms are equipped to handle the lower quality data collected during user intake exams and remove any interfering sounds.
With TytoCare’s CE Mark approved and FDA-cleared handheld examination kit, users can perform comprehensive physical exams of the heart, skin, ears, throat, abdomen and lungs, and measure heart rate, body temperature and blood oxygen levels, which are key for treating many acute and chronic conditions.
This capability gives health care clinicians vital clinical data necessary for them to monitor, diagnose and treat patients.