What You Should Know:
– TytoCare has received CE Mark approval for its AI-backed Tyto Lung Sounds Analyzer, a web-based software system 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.
– The Lung Sounds Analyzer will further enable physicians to better diagnose respiratory conditions remotely. 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 Sounds Analyzer.
Lung Sounds Analyzer Background
TytoCare developed the Lung Sounds 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 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 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,” 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.