FDA Radiology AI Devices

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.