Resmed Announces Small, Easy to Use Home Sleep Apnea Test, NightOwl™, Now Available Across the US

Rhea-AI Summary

Resmed (NYSE: RMD) has announced the nationwide U.S. availability of NightOwl™, an FDA-cleared home sleep apnea test. The device is a fingertip sensor designed to diagnose obstructive sleep apnea (OSA) from home, addressing a critical healthcare gap where 80% of OSA cases remain undiagnosed.

The disposable device can record up to 10 nights of sleep data per patient, utilizing peripheral arterial tonometry technology to measure blood flow changes, oxygen saturation, and pulse rate. Key features include auto-scored results, integration with Resmed's Somnoware, and pairing with the myAir™ app for user guidance.

NightOwl's clinical validation through a multicenter study demonstrated close agreement with expert-scored sleep lab testing PSG in measuring sleep apnea severity. The technology aims to simplify the diagnostic process for both healthcare providers and patients, supporting timely diagnosis and treatment of OSA, which affects nearly one billion people globally.

Positive

• FDA clearance obtained for the NightOwl device
• Addresses large untapped market with 80% of OSA cases undiagnosed
• Clinical validation through multicenter study showing accuracy comparable to lab testing
• Reduces operational costs with disposable design eliminating need for returns and cleaning

Negative

• Device to single patient use (disposable after 10 nights)
• Requires separate purchase of Somnoware integration software

News Market Reaction – RMD

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On the day this news was published, RMD declined 4.33%, reflecting a moderate negative market reaction.

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FDA-cleared home sleep test provides an effective and simplified solution to obstructive sleep apnea testing and diagnosis

SAN DIEGO, April 03, 2025 (GLOBE NEWSWIRE) -- Resmed (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing, and care delivered in the home, today announced its home sleep apnea test, NightOwl™, is now available across the United States. NightOwl is an FDA-cleared home sleep apnea test (HSAT) designed to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea (OSA) from the comfort of an individual’s home.

OSA, a sleep disorder where breathing repeatedly stops during sleep due to blocked upper airways, affects nearly one billion people globally¹, yet approximately 80% of cases remain undiagnosed and untreated². Additionally, a recent study published in The Lancet Respiratory Medicine found that treating OSA with CPAP therapy can significantly reduce the risk of death³ - underscoring the importance of accessible and simplified diagnostic options. NightOwl makes it easy to detect OSA with a small sensor worn on the fingertip and simple, easy-to-use 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,” said Carlos M. Nunez, M.D., Chief Medical Officer at Resmed. “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 that is clinically validated against polysomnography (PSG), saving time for sleep specialists and clinicians.
• Seamless Integration with Resmed’s Somnoware: Enhances diagnostic workflows by integrating with leading 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, a noninvasive method that 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 indicating a high degree of accuracy that were reviewed by the FDA⁴.

NightOwl is now widely available across the United States. Individuals interested in NightOwl should speak with their healthcare provider for more information. To learn more, visit: https://www.resmed.com/en-us/health-professionals/products/home-sleep-testing/nightowl/

About Resmed  
Resmed (NYSE: RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.

For Media Caela Shay news@resmed.com	For Investors  Mike Ott or Wendy Wilson  investorrelations@resmed.com

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¹ Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. PMID: 31300334; PMCID: PMC7007763.
² Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 ;20(9):705-6
³ Benjafield et al; Positive airway pressure therapy and all-cause and cardiovascular mortality in people with obstructive sleep apnoea: a systematic review and meta-analysis of randomised controlled trials and confounder-adjusted, non-randomised controlled studies; Lancet Respir Med 2025
⁴ Van Pee, B et al; A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry; Sleep 2022

FAQ

What are the key features of RMD's new NightOwl sleep apnea test?

NightOwl is a fingertip sensor that records 10 nights of sleep data, offers auto-scored results, integrates with Somnoware, and pairs with myAir app. It's fully disposable and uses peripheral arterial tonometry technology.

How accurate is RMD's NightOwl compared to traditional sleep lab testing?

According to a multicenter validation study, NightOwl showed close agreement with expert-scored sleep lab testing (PSG) in measuring sleep apnea severity for both 3% and 4% hypopnea desaturation scoring rules.

What market gap does RMD's NightOwl address in sleep apnea testing?

NightOwl addresses the 80% of undiagnosed OSA cases among the nearly one billion people affected globally, by providing an accessible, at-home testing solution.

How does RMD's NightOwl home sleep test work?

NightOwl uses peripheral arterial tonometry to measure blood flow changes, oxygen saturation, and pulse rate through a fingertip sensor, transmitting data to a cloud-based platform for physician analysis.