FDA Radiology AI Devices

Ascent Cardiorespiratory Diagnostic Software is a standalone application used with hardware to measure, collect, and analyze lung and cardiopulmonary function tests. It helps clinicians, such as pulmonologists and cardiologists, diagnose lung and heart-related conditions by processing test data from devices like spirometers and body plethysmographs. The software provides detailed pulmonary and cardiopulmonary metrics, manages diagnostic data, and facilitates interpretation and reporting, improving diagnostic workflow.

The Huxley SANSA Home Sleep Apnea Test is a wearable device that records various physiological signals such as oxygen saturation, heart rate, chest movement, snoring, and sleep stages. It uses AI/ML algorithms in a cloud-based platform to analyze these signals and assist healthcare professionals in evaluating sleep-related breathing disorders like sleep apnea, both in clinical and home settings.

Tyto Insights for Crackles Detection is an AI-powered software that analyzes lung sound recordings made by a compatible stethoscope to detect abnormal lung sounds called crackles. It supports clinicians by providing automated detection to help evaluate lung health in both adults and children aged two years and older. The device aids healthcare providers in clinical decision-making by highlighting recordings suggestive of crackles, which may indicate underlying lung conditions.

Tyto Insights for Wheeze Detection is an AI-powered software tool that analyzes lung sounds recorded by the FDA-cleared Tyto Stethoscope to automatically detect the presence of wheezing. This helps clinicians by providing decision support in respiratory assessments for adults and children aged 2 years and older. It offers clear positive or negative wheeze detection results through a web interface accessible to healthcare providers and patients, improving remote and point-of-care lung sound evaluation.