FDA Radiology AI Devices

The Happy Health Home Sleep Test is a software device that processes data collected from wearable sensors, such as a smart ring, to help healthcare providers evaluate adults suspected of sleep apnea. It records, analyzes, and presents biophysical signals like movement and blood flow to produce sleep parameters including apnea-hypopnea index and total sleep time, aiding clinicians in the diagnosis of sleep-related breathing disorders.

TipTraQ is a wearable fingertip device designed to assist in evaluating and diagnosing sleep apnea in adults. It collects physiological data like photoplethysmogram (PPG) and movement via accelerometer, then uses cloud-based AI algorithms to analyze the data and determine critical sleep parameters such as total sleep time, REM time, and apnea-hypopnea index. This helps clinicians diagnose sleep apnea more efficiently both at home and in clinical settings.

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.

The Belun Sleep System BLS-100 is a wearable device designed for adult patients suspected of sleep apnea. It consists of a sensor ring worn on the user's index finger overnight to collect biophysical signals such as oxygen saturation and pulse, which are then analyzed by AI-powered software to help healthcare professionals assess the severity of sleep-related breathing disorders in both clinical and home settings.