Sunrise Group Gains FDA Clearance for Home Sleep Test

Why this is here: Sunrise Air incorporates a microphone to analyze snoring, alongside sensors for airflow, oxygen saturation, and pulse rate, offering a more detailed picture of a patient’s sleep.

Sunrise Group received US Food and Drug Administration clearance for Sunrise Air, a rechargeable at-home sleep test, in the United States. The device measures mandibular jaw movements and now includes sensors for airflow, oxygen saturation, pulse rate, and snoring. It uses artificial intelligence to analyze data and create sleep reports for doctors.

Sunrise Group intends the test to improve access to sleep apnea diagnosis for the over 900 million people worldwide affected. Traditional sleep studies require visits to laboratories and can involve long wait times. The new device is lightweight and designed for multiple nights of use, eliminating disposable parts.

The company recently secured $29 million in funding to expand clinical services through Dreem Health, a virtual sleep clinic. While the device improves upon single-night sleep studies, it remains to be seen how widely it will be adopted by clinicians and patients. The company plans to continue refining its technology and expanding access to sleep care.