Resmed Announces Small, Easy to Use Home Sleep Apnea Test, NightOwl™, Now Available Across the US
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.
Resmed (NYSE: RMD) ha annunciato la disponibilità a livello nazionale negli Stati Uniti di NightOwl™, un test per l'apnea notturna a domicilio approvato dalla FDA. Il dispositivo è un sensore da dito progettato per diagnosticare l'apnea ostruttiva del sonno (OSA) da casa, affrontando una criticità nel settore sanitario in cui l'80% dei casi di OSA rimane non diagnosticato.
Il dispositivo usa e getta può registrare fino a 10 notti di dati sul sonno per paziente, utilizzando la tecnologia della tonometria arteriosa periferica per misurare le variazioni del flusso sanguigno, la saturazione di ossigeno e la frequenza cardiaca. Tra le caratteristiche principali ci sono i risultati auto-valutati, l'integrazione con Somnoware di Resmed e la sincronizzazione con l'app myAir™ per la guida all'utente.
La validazione clinica di NightOwl attraverso uno studio multicentrico ha dimostrato una stretta corrispondenza con i test PSG nei laboratori del sonno valutati da esperti nella misurazione della gravità dell'apnea notturna. La tecnologia mira a semplificare il processo diagnostico sia per i fornitori di assistenza sanitaria che per i pazienti, supportando una diagnosi e un trattamento tempestivi dell'OSA, che colpisce quasi un miliardo di persone a livello globale.
Resmed (NYSE: RMD) ha anunciado la disponibilidad a nivel nacional en EE. UU. de NightOwl™, un test de apnea del sueño a domicilio aprobado por la FDA. El dispositivo es un sensor de dedo diseñado para diagnosticar la apnea obstructiva del sueño (OSA) desde casa, abordando una brecha crítica en la atención médica donde el 80% de los casos de OSA permanecen sin diagnosticar.
El dispositivo desechable puede registrar hasta 10 noches de datos de sueño por paciente, utilizando tecnología de tonometría arterial periférica para medir los cambios en el flujo sanguíneo, la saturación de oxígeno y la frecuencia del pulso. Las características clave incluyen resultados autoevaluados, integración con Somnoware de Resmed y emparejamiento con la aplicación myAir™ para la orientación del usuario.
La validación clínica de NightOwl a través de un estudio multicéntrico demostró una estrecha concordancia con las pruebas PSG en laboratorios de sueño evaluadas por expertos en la medición de la gravedad de la apnea del sueño. La tecnología tiene como objetivo simplificar el proceso de diagnóstico tanto para los proveedores de atención médica como para los pacientes, apoyando un diagnóstico y tratamiento oportunos de la OSA, que afecta a casi mil millones de personas en todo el mundo.
Resmed (NYSE: RMD)는 미국 전역에서 NightOwl™의 사용 가능성을 발표했습니다. 이는 FDA에서 승인한 가정용 수면 무호흡 테스트입니다. 이 장치는 집에서 폐쇄성 수면 무호흡증(OSA)을 진단하기 위해 설계된 손가락 센서로, OSA 사례의 80%가 진단되지 않는 중요한 의료 격차를 해결하고 있습니다.
일회용 장치는 환자당 최대 10일 밤의 수면 데이터를 기록할 수 있으며, 말초 동맥 혈압 측정 기술을 사용하여 혈류 변화, 산소 포화도 및 맥박을 측정합니다. 주요 기능으로는 자동 점수화 결과, Resmed의 Somnoware와의 통합 및 사용자 안내를 위한 myAir™ 앱과의 페어링이 있습니다.
NightOwl의 임상 검증은 다기관 연구를 통해 수면 무호흡의 심각성을 측정하는 데 있어 전문가가 평가한 수면 검사 PSG와 밀접한 일치를 보여주었습니다. 이 기술은 의료 제공자와 환자 모두를 위한 진단 과정을 간소화하여 OSA의 시기 적절한 진단 및 치료를 지원하는 것을 목표로 하며, 이는 전 세계에서 거의 10억 명에게 영향을 미칩니다.
Resmed (NYSE: RMD) a annoncé la disponibilité nationale aux États-Unis de NightOwl™, un test d'apnée du sommeil à domicile approuvé par la FDA. L'appareil est un capteur de doigt conçu pour diagnostiquer l'apnée obstructive du sommeil (OSA) à domicile, comblant une lacune critique dans les soins de santé où 80 % des cas d'OSA restent non diagnostiqués.
Ce dispositif jetable peut enregistrer jusqu'à 10 nuits de données de sommeil par patient, utilisant la technologie de tonométrie artérielle périphérique pour mesurer les variations du flux sanguin, la saturation en oxygène et la fréquence cardiaque. Les caractéristiques clés comprennent des résultats auto-évalués, une intégration avec Somnoware de Resmed et un couplage avec l'application myAir™ pour l'orientation de l'utilisateur.
La validation clinique de NightOwl à travers une étude multicentrique a démontré une correspondance étroite avec les tests PSG effectués dans des laboratoires de sommeil par des experts pour mesurer la gravité de l'apnée du sommeil. La technologie vise à simplifier le processus de diagnostic tant pour les prestataires de soins de santé que pour les patients, soutenant un diagnostic et un traitement opportun de l'OSA, qui touche près d'un milliard de personnes dans le monde.
Resmed (NYSE: RMD) hat die landesweite Verfügbarkeit von NightOwl™ in den USA angekündigt, einem von der FDA zugelassenen Heimtest für Schlafapnoe. Das Gerät ist ein Fingersensor, der entwickelt wurde, um obstruktive Schlafapnoe (OSA) von zu Hause aus zu diagnostizieren und damit eine kritische Lücke im Gesundheitswesen zu schließen, in der 80 % der OSA-Fälle unentdeckt bleiben.
Das Einweggerät kann bis zu 10 Nächte Schlafdaten pro Patient aufzeichnen und nutzt die Technologie der peripheren arteriellen Tonometrie, um Veränderungen des Blutflusses, der Sauerstoffsättigung und der Herzfrequenz zu messen. Zu den Hauptmerkmalen gehören automatisch bewertete Ergebnisse, die Integration mit Resmeds Somnoware und die Kopplung mit der myAir™-App zur Benutzeranleitung.
Die klinische Validierung von NightOwl durch eine multizentrische Studie zeigte eine enge Übereinstimmung mit den von Experten bewerteten Schlaflaboruntersuchungen (PSG) zur Messung der Schwere der Schlafapnoe. Die Technologie zielt darauf ab, den Diagnoseprozess sowohl für Gesundheitsdienstleister als auch für Patienten zu vereinfachen und eine zeitnahe Diagnose und Behandlung der OSA zu unterstützen, die fast eine Milliarde Menschen weltweit betrifft.
- 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
- Device to single patient use (disposable after 10 nights)
- Requires separate purchase of Somnoware integration software
Insights
Resmed's nationwide launch of the NightOwl home sleep apnea test represents a significant advancement in sleep diagnostics. The device's fingertip sensor design dramatically simplifies testing compared to traditional polysomnography, which typically requires multiple sensors attached throughout the body. This minimally intrusive approach addresses a critical barrier to diagnosis for the estimated 80% of obstructive sleep apnea (OSA) cases that remain undetected.
The device's capability to record up to 10 consecutive nights of sleep data captures night-to-night variability, potentially offering more comprehensive insights than single-night clinical studies. The peripheral arterial tonometry technology has been validated against gold-standard polysomnography, with the multicenter validation study confirming diagnostic accuracy.
From a clinical workflow perspective, the auto-scoring algorithm and cloud-based platform address significant pain points in sleep medicine - the time-consuming process of manually scoring sleep studies and the logistical challenges of device management. The fully disposable design eliminates reprocessing requirements and device return logistics, streamlining the diagnostic process for healthcare providers.
The integration with Resmed's existing Somnoware platform and myAir app creates a connected ecosystem that could improve patient engagement and simplify provider workflows. Given the recent Lancet study demonstrating mortality reduction with CPAP therapy, this easier pathway to diagnosis could have substantial clinical impact by connecting more patients with potentially life-saving treatment.
Resmed's NightOwl launch strategically expands their product ecosystem beyond treatment devices into the diagnostic space, addressing a critical bottleneck in the sleep apnea care pathway. With nearly one billion people affected by OSA globally and 80% remaining undiagnosed, this represents an enormous untapped market opportunity.
The disposable single-patient design creates a recurring revenue model rather than the one-time capital equipment sales typical of traditional sleep lab diagnostics. This aligns with healthcare's shift toward decentralized care models and could accelerate patient conversion to Resmed's core CPAP therapy devices.
The technology addresses several key market barriers: the inconvenience of overnight lab studies, sleep lab capacity, and the complexity of traditional testing equipment. By simplifying the diagnostic process, Resmed potentially expands their addressable market while strengthening their integrated sleep solution ecosystem.
The timing is particularly strategic given increasing awareness of OSA's health impacts, highlighted by the cited Lancet study showing CPAP therapy's mortality benefits. The device's FDA clearance and clinical validation provide regulatory confidence, while the seamless integration with Resmed's existing software platforms enhances their competitive position against standalone diagnostic tools.
While the article doesn't address pricing or reimbursement models, which will significantly impact adoption rates, this launch positions Resmed to capture more patients at the diagnostic entry point of the sleep therapy journey, potentially increasing downstream therapy device sales.
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
“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
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
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