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Sunrise Receives FDA Clearance for Its At-home Sleep Apnea Test

Original Article By: BusinessWire

Summarized By: Neurobit

Sunrise, a Belgium-based scale-up company, has announced that the U.S. Food and Drug Administration (FDA) has approved the use of their second-generation at-home sleep apnea test. This test utilizes artificial intelligence (AI) to aid in the diagnosis of obstructive sleep apnea and sleep-related breathing disorders. The device measures sleep through the bio-signal of Mandibular Jaw Movements (MJM), which has been studied for decades, in addition to the traditional signals of airflow and oximetry.

Laurent Martinot, CEO and co-founder of Sunrise, stated that the integration of the powerful MJM signal with the traditional signals provides a new level of clinical information and ease of use that has never been seen before in-home sleep testing. He added that the company has clinically validated its sensor against the gold standard of polysomnography on thousands of patients to measure sleep-disordered breathing.

Atul Malhotra, a board-certified pulmonologist and intensivist, and research chief of Pulmonary, Critical Care and Sleep Medicine at UC San Diego Health, commented on the new device. He noted that home sleep tests have come a long way in recent years and are now well-established in diagnosing sleep disorders in appropriate patients. However, he also highlighted that there remain shortcomings, and the Sunrise device appears to address some of these gaps in its ability to convey relevant information about the 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.

One of the new features available on this at-home sleep apnea test is the ability for patients to complete multi-night testing. Malhotra explained that incorporating a multi-night capability will improve diagnostic confidence as night-to-night variability in sleep studies is well documented and capturing longitudinal data over time is important.

Sunrise's AI-based solution provides a proven technology for expanding access and reaches across health systems and clinics with the goal of improving health outcomes. The technology captures MJM with a lightweight sensor placed on the chin, which records the jaw's movements. Data is collected through an app, analyzed with an algorithm using AI, and made available to healthcare providers through a secured online portal.


BusinessWire. (2022, August 10). Sunrise Receives FDA Clearance for Its At-home Sleep Apnea Test. BusinessWire. Retrieved February 13, 2023, from

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