Summary: Resmed has completed scaling up the availability of NightOwl, its FDA-cleared fingertip home sleep test acquired from Ectosense, now making the simplified, disposable OSA diagnostic device broadly accessible across the US market.
Key Takeaways:
- Resmed has scaled up distribution of the NightOwl home sleep test (HST) across the US after limited availability since its acquisition from Ectosense in 2021.
- NightOwl simplifies OSA diagnosis by using a disposable fingertip sensor connected to a smartphone, enabling convenient at-home testing for patients.
- NightOwl integrates with Resmed’s Somnoware sleep lab management software and pairs with the myAir app for streamlined diagnostics and patient support.
Resmed has been working to integrate NightOwl into its portfolio since it acquired the home sleep test (HST) from Ectosense in 2021. “This important work allowed Resmed to scale NightOwl to gradually meet US demand,” the company said in an emailed statement. “This work is now complete, and Resmed is excited to offer NightOwl broadly to US customers.” So while NightOwl has been available on a limited commercial release basis before March 24, 2025, it is now available across the United States.
Cleared by the US Food and Drug Administration, NightOwl is designed to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea (OSA). It uses a small sensor worn on the fingertip and simple digital platforms for both individuals and providers. By making OSA testing more convenient and accessible, NightOwl supports Resmed’s vision to help people achieve their full potential through better sleep and breathing, with care delivered in their own home.
“Now more than ever, people want healthcare experiences that are easy, convenient, and accessible, however, navigating sleep apnea testing can be complex,” says Carlos M. Nunez, MD, chief medical officer at Resmed, in a release. “With NightOwl, people can easily complete a sleep apnea test from the comfort of home using just a fingertip sensor and a smartphone. It also simplifies the process for providers. This is a meaningful step forward in Resmed’s mission to deliver life-changing health technology that people love.”
NightOwl is a disposable HSAT device that records up to 10 nights of sleep data for a single patient, capturing night-to-night variability and providing clinicians with a comprehensive view of an individual’s sleep patterns. Sleep data is sent remotely to a cloud-based diagnostic platform for physician analysis and review, enabling quick interpretation, streamlining diagnostic workflows, and helping individuals receive more timely diagnoses, if applicable.
Additional key features of NightOwl, include:
- Auto-Scored Results: Raw patient data is autoscored with an algorithm clinically validated against polysomnography (PSG).
- Seamless Integration with Resmed’s Somnoware: Enhances diagnostic workflows by integrating with sleep lab management software, purchased separately.
- Fully Disposable: Eliminates the need for device returns, cleaning, or reprocessing, reducing operational burdens for healthcare providers.
- Pairing with Resmed’s myAir app: The device pairs with the myAir app, providing individuals with step-by-step guidance throughout the testing process.
NightOwl uses peripheral arterial tonometry technology, which measures blood flow changes, oxygen saturation, and pulse rate changes to detect OSA. According to a multicenter validation study, NightOwl results using peripheral arterial tonometry technology showed close agreement with expert-scored sleep lab testing PSG in its estimate of sleep apnea severity and clinical performance. This publication serves as additional clinical validation of the diagnostic accuracy of NightOwl, for both 3% and 4% hypopnea desaturation scoring rules, in addition to the studies reviewed by the FDA.
