Sunrise receives FDA clearance for its second-generation at-home sleep apnea test!

21 February 2023

We are thrilled to announce that Sunrise has received FDA clearance for its second-generation home sleep test with airflow, oximetry, and the power of mandibular jaw movement (MJM) all from a single point of contact. The addition of new signals makes to the already powerful MJM makes the technology fits current reimbursement frameworks.

New features include the ability for patients to complete multi-night testing.

“Night-to-night variability in sleep studies is well documented and incorporating a multi-night capability in an economical manner, allowing to capture longitudinal data over time, will improve diagnostic confidence,” explained A. Malhotra, MD.

This is a significant milestone for the company to improve the lives of patients through better sleep.

Atul Malhotra, MD, board-certified pulmonologist, intensivist and research chief of Pulmonary, Critical Care and Sleep Medicine at UC San Diego Health, commented : “Home sleep tests have come a long way in recent years and are now well established in diagnosing sleep disorders in appropriate patients. Despite this success there remain shortcomings and the Sunrise device appears to close some of these gaps in its ability to convey relevant information about hypoxic burden and total sleep time spent with increased respiratory effort, a key component of obstructive sleep apnea that has been linked to cardiovascular and mortality outcomes".

We are excited to continue to push the boundaries of sleep technology!

Read the news article on Business Wire.