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TytoCare Receives CE Mark Approval for its Lung Sounds Analyzer

The approval will aid European healthcare providers in clinically assessing lung sound data to determine whether wheezing is detected

New York, NY — January 5, 2022 — TytoCare, the global health care industry’s first all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams, announced today that it received CE Mark approval for its AI-backed Tyto Lung Sounds Analyzer. The Tyto Lung Sounds Analyzer is a web-based software module that adds additional capabilities to the existing TytoCare solution, designed to aid in the clinical assessment of lung auscultation sound data by analyzing recorded lung sounds to determine whether wheezing is detected within the recording, helping physicians to better diagnose respiratory conditions remotely.

The Tyto Lung Sounds Analyzer is a clinical decision support standalone Software as a Medical Device (SaMD) that is intended to inform healthcare professionals about the potential presence of an abnormal breath sound in respiratory recordings that may be wheezing in adults and children. The CE Mark paves the way for the immediate European rollout of TytoCare’s Lung Sounds Analyzer Software that processes recordings from the CE marked and FDA-cleared off-the-shelf compatible electronic TytoCare Stethoscope. The company is currently seeking FDA clearance for the Lung Sound Analyzer.

TytoCare developed the Lung Sound Analyzer based on its vast database of clinical exams. Analysis of this robust big data, in combination with clinical literature, fuels the decision support algorithms that powers the Lung Sounds Analyzer. The algorithms, which required testing on the large number of exam recordings unique to TytoCare, are also uniquely equipped to handle lower quality data collected during user intake exams and to remove any interfering sounds. The company also worked with experienced pulmonologists and general practitioners to develop the analyzer.

“Receiving the CE Mark on the Lung Sound 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,” said Dedi Gilad, CEO and co-founder of TytoCare. “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.”

TytoCare’s CE Mark approved and FDA-cleared handheld examination kit enables users to 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 allows health care clinicians to gain the vital clinical data they require to monitor, diagnose, and treat patients and avoid unnecessary in-person visits.

About TytoCare

TytoCare is a telehealth company using AI to transform primary care by putting health in the hands of consumers. TytoCare seamlessly connects people to clinicians to provide the best virtual home examination and diagnosis solutions. Its solutions are designed to enable a comprehensive medical exam from any location and include a hand-held, all-in-one tool for examining the heart, lungs, skin, ears, throat, abdomen, and body temperature; a complete telehealth platform for sharing exam data, conducting live video exams, and scheduling visits; a cloud-based data repository with analytics; and built-in guidance technology and machine learning algorithms to ensure accuracy and ease of use for patients and insights for healthcare providers. Co-founded by Dedi Gilad and Ofer Tzadik in 2012, TytoCare has FDA and CE clearances and has partnered with over 170 major health systems, health plans, and strategic partners in the U.S., Europe, Asia, Latin America, and Israel. To watch a demo video, click here.

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