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Tyto Insights for Wheeze Detection
The “Tyto Insights for Wheeze Detection” is an over-the-counter artificial intelligence (AI) enabled decision supportsoftware system used in the evaluation of lung sounds in adults and pediatrics. It automatically analyses the acousticsignal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specificabnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lungsounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights forWheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and otherrelevant patient data.
Details
Device typeElectronic acoustic stethoscope: An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].
FDA categoryAbnormal Breath Sound Device
Device ID07290016672886
AvailabilityOver the counter
MRI safetyLabeling does not contain MRI Safety Information