Sunrise’s sleep apnea detection tool receives FDA 510(k) clearance

Belgian sleep-focused digital health startup Sunrise received FDA 510(k) clearance for its home sleep apnea test that’s placed on a user’s chin at night. 

The test utilizes a sensor that analyzes bio-signals from mandibular jaw movements, which can help calculate respiratory disturbance often found in sleep apnea patients. It also evaluates airflow and oximetry during sleep to aid in diagnosing sleep-related breathing disorders and sleep apnea. 

Results are then sent to an AI-enabled app that analyzes the data, which users can share with a healthcare provider via an online portal. 


Professional sleep apnea tests often involve overnight monitoring at a sleep center, but home testing companies have emerged that allow patients to test for this disorder at home. 

In 2021, UK-based wearable medical device company Acurable‘s AcuPebble SA100 received FDA 510(k) clearance. The device senses, records and interprets physiological signals, like a patient’s respiratory pattern, while they sleep to prescreen for obstructive sleep apnea.

ASX-listed ResApp Health also received 510(k) clearance for SleepCheckRx, a mobile sleep apnea screening app that screens for the condition by analyzing breathing and snoring sounds recorded via phone. 



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