FDA grants 510(k) clearance to at-home sleep apnea test sensor

The FDA has granted 510(k) clearance to an at-home test device that can diagnose obstructive sleep apnea and other sleep-related breathing disorders, according to a press release.

According to the release, this at-home sleep apnea test (Sunrise) involves a lightweight sensor on the chin that measures mandibular jaw movements, as well as airflow and oximetry during sleep. These data are then recorded on an app and assessed with artificial intelligence to help diagnose users.

Additionally, the device includes a secure online portal where health care providers can access all this captured information.

This sensor will also be able to perform multi-night testing, according to the release.

“We have clinically validated our sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing,” Laurent Martinot, Sunrise CEO and co-founder, said in the release.