News

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. 

THE LARGER TREND

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. 

Avatar

admin

About Author

You may also like

News

Senior-focused VR company MyndVR will be covered by New York insurer

VR digital therapeutic company MyndVR announced AgeWell New York’s insurance plans for Medicare and Medicaid patients would cover its senior-focused
News

GoodRx shared health data with Google and Facebook, FTC says

The Federal Trade Commission on Wednesday alleged drug-cost and telehealth platform GoodRx shared consumers’ personal health information with third parties