FDA Clears Sunrise’s AI-Powered At-Home Sleep Apnea Test

Sunrise’s second-generation artificial intelligence (AI)-powered at-home sleep apnea test has received FDA clearance to aid in the diagnosis of obstructive sleep apnea and sleep-related breathing disorders using a novel way to measure sleep — mandibular jaw movement bio-signals.

The device allows for data collection over multiple nights, as night to night variability in sleep studies is well documented and the multi-night capability “will improve diagnostic confidence,” the company said.

A lightweight sensor placed on the chin records the jaw’s movements, sending the data along with airflow and oximetry data for analysis by the AI algorithm.