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.
An external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. 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 display.