Resmed Receives FDA Clearance for Personalized Therapy Comfort Settings, to be Marketed as Smart Comfort, an AI-Enabled, Digital Medical Device That Helps Personalize CPAP Therapy

Resmed (NYSE: RMD) received FDA clearance on December 8, 2025 for Personalized Therapy Comfort Settings, marketed as Smart Comfort, an AI-enabled digital medical device that recommends individualized CPAP comfort settings.

Rhea-AI Summary

Resmed (NYSE: RMD) received FDA clearance on December 8, 2025 for Personalized Therapy Comfort Settings, marketed as Smart Comfort, an AI-enabled digital medical device that recommends individualized CPAP comfort settings. Smart Comfort uses machine learning trained on more than 100 million nights of de-identified sleep data to adjust pressure ramp, exhale pressure relief and easing-into-therapy settings. A limited U.S. beta for new myAir users paired with AirSense 11 will launch in early 2026, followed by a broader U.S. rollout later in 2026. The feature provides non-prescription comfort recommendations and aims to improve engagement and sustained adherence without changing prescribed therapy settings.

Positive

• FDA clearance granted on December 8, 2025
• Machine learning trained on >100 million nights of data
• Limited U.S. beta launching early 2026 for myAir new users
• Broader U.S. rollout planned later in 2026

Negative

• Initial availability limited to new myAir users paired with AirSense 11
• Smart Comfort provides non-prescription comfort settings only

Argus Dec 8 session

-2.54% close to close Open Argus

Details

News Market Reaction – RMD

On Dec 8, the day this news came out, RMD closed 2.54% below the previous close.

Data tracked by StockTitan Argus for the Dec 8 session.

Key Figures

Real-world sleep data: more than 100 million nights OSA prevalence (U.S.): 61 million people Projected OSA (U.S. 2050): nearly 77 million people +2 more

Real-world sleep data

more than 100 million nights

Dataset used for Smart Comfort machine-learning algorithms

OSA prevalence (U.S.)

61 million people

Estimated current U.S. obstructive sleep apnea impact

Projected OSA (U.S. 2050)

nearly 77 million people

Expected U.S. obstructive sleep apnea burden by 2050

Smart Comfort launch timing

early 2026

Limited U.S. beta launch for new myAir users

Broader U.S. rollout

later in 2026

Planned expansion to additional new myAir users

Historical Context

5 past events · Latest: Oct 30

5 events

1. Oct 30

   Earnings results

   24h Move

   -0.5%

   Strong Q1 2026 revenue, margin expansion, and EPS growth.

2. Oct 09

   Earnings preview

   24h Move

   -2.1%

   Announcement of upcoming Q1 2026 earnings release and webcast.

3. Sep 16

   Conference participation

   24h Move

   -0.3%

   Planned presentation at Bank of America Global Healthcare Conference.

4. Sep 03

   Sleep initiative launch

   24h Move

   +1.7%

   Launch of Sleep Institute to advance global sleep health science.

5. Aug 27

   OSA prevalence study

   24h Move

   -1.1%

   Study projecting large U.S. OSA burden and future growth.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cpap therapy, obstructive sleep apnea, apnea-hypopnea index (ahi), machine learning, +2 more

6 terms

cpap therapy medical

"Smart Comfort is the first FDA-cleared AI-enabled medical device that recommends..."

CPAP therapy is a medical treatment that delivers a steady flow of air through a mask while a person sleeps to keep the airway open and prevent pauses in breathing, commonly used for sleep apnea. Investors care because CPAP devices, masks and replaceable parts create a recurring-product market influenced by patient adherence, clinical effectiveness, insurance reimbursement and regulatory approvals, all of which affect sales, service revenue and long-term growth.

obstructive sleep apnea medical

"settings to help people with obstructive sleep apnea (OSA) start and stay..."

Obstructive sleep apnea is a common medical condition where the throat repeatedly narrows or closes during sleep, causing short pauses in breathing, drops in blood oxygen and fragmented rest. It matters to investors because it creates ongoing demand for medical devices, diagnostics, treatments and sleep-monitoring services, and it can affect population health, workforce productivity and healthcare spending—like a recurring leak in a system that requires continual repair and monitoring.

apnea-hypopnea index (ahi) medical

"user information, such as age, gender and Apnea-Hypopnea Index (AHI), to recommend..."

AHI is a medical score that counts how many times a person stops breathing (apneas) or takes very shallow breaths (hypopneas) per hour of sleep, and it is used to classify the severity of sleep-disordered breathing. Investors care because AHI is a common, measurable outcome that drives diagnoses, treatment decisions, device sales and regulatory approvals; think of it as a fuel gauge or scoreboard that shows whether a therapy or product is actually improving a patient’s breathing at night.

machine learning technical

"Technology uses real-world sleep data and machine learning to help people..."

Machine learning is a set of computer programs that learn patterns from large amounts of data and improve their predictions or decisions over time, like a recipe that gets better each time it’s adjusted based on taste tests. For investors it matters because these systems can speed up analysis, spot trends or risks humans might miss, automate routine work, and potentially create competitive advantages or cost savings that affect a company’s performance.

View in glossary

real-world evidence medical

"The FDA submission was supported by retrospective real-world evidence showing that..."

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

ai-enabled medical device technical

"Smart Comfort is the first FDA-cleared AI-enabled medical device that recommends..."

A device that combines medical hardware with software that learns from data to help detect, diagnose, monitor, or treat health conditions. Think of it as medical equipment with a smart assistant inside that can improve over time by recognizing patterns in scans, signals, or patient records. Investors care because these products can drive faster adoption, recurring software updates or subscriptions, regulatory hurdles, and greater competitive advantage — all of which affect revenue, costs, and risk profiles.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Technology uses real-world sleep data and machine learning to help people with sleep apnea start and stay on therapy 

SAN DIEGO, Dec. 08, 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 it has received U.S. Food and Drug Administration (FDA) clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort.

Smart Comfort is the first FDA-cleared AI-enabled medical device that recommends personalized comfort settings to help people with obstructive sleep apnea (OSA) start and stay on CPAP therapy. Smart Comfort will launch in early 2026 in a limited U.S. beta version for new users of myAir™, Resmed's consumer sleep companion app, paired with a Resmed AirSense™ 11 device. It will be followed by a broader U.S. rollout to new myAir users later in 2026.

CPAP therapy is not one-size-fits-all. Addressing common therapy issues, like comfort and mask fit, early can promote long-term adherence. Smart Comfort leverages Resmed’s proprietary machine-learning algorithms, drawing on more than 100 million nights of de-identified, real-world sleep data and user information, such as age, gender and Apnea-Hypopnea Index (AHI), to recommend individualized comfort settings for CPAP therapy delivered by Resmed’s market leading AirSense 11 devices. These include settings that help ease users into therapy, adjust how gradually an AirSense 11 increases pressure and reduce pressure on exhale. Smart Comfort was developed with clinical oversight and ethical data use in compliance with privacy laws, considering quality and patient safety at every stage.

“For people new to CPAP therapy, personalized comfort settings can help them adjust faster and more comfortably, improving confidence and overall health,” said Justin Leong, Chief Product Officer at Resmed. “Smart Comfort’s FDA clearance marks an important milestone for the future of personalized, data-driven care. It’s another example of how we’re using technology and real-world evidence to make sleep health more personal, accessible and effective.”

The FDA submission was supported by retrospective real-world evidence showing that Resmed AirSense 10 and 11 users whose comfort settings matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings. These findings demonstrate that personalized comfort adjustments can help improve the therapy experience without compromising efficacy.

In the U.S., OSA impacts an estimated 61 million people and is expected to rise to nearly 77 million by 2050.¹ Left untreated, OSA can significantly impact health and quality of life, increasing the risk of high blood pressure, heart disease, type 2 diabetes and stroke.² CPAP therapy, the gold standard treatment for sleep apnea, can significantly reduce the risk of death in people with OSA.³

For healthcare providers, Smart Comfort offers a solution to help streamline user setup and follow-up and reduce manual adjustments so clinicians can devote more attention to clinical decision-making and patient support. By getting people engaged in their therapy from day one, Smart Comfort helps standardize the comfort settings workflow and builds user confidence that their settings are personalized for them. These non-prescription comfort settings are designed to support CPAP therapy device usage – not alter prescribed therapy settings or therapy efficacy.

Smart Comfort is part of Resmed’s connected, personalized sleep-health ecosystem – combining AI, cloud-connected Resmed devices and digital tools to help make sleep health more personal and support therapy efficacy. Together with other myAir features, including Dawn™, Therapy Control and Streaks, these innovations demonstrate Resmed’s commitment to responsible, data-driven innovation that helps more people start and stay on therapy.

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	For Investors
Caela Shay	Salli Schwartz
Caela.shay@resmed.com	Salli.Schwartz@resmed.com
news@resmed.com	investorrelations@resmed.com

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¹ Boers E, et al. Lancet Respir Med. 2025;13(12):1078–1086.
² Yeghiazarians Y, et al. Circulation. 2021;144(3):E56–E67.
³ Benjafield AV, et al. Lancet Respir Med. 2025;13(5):403–413.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Resmed (RMD) announce on December 8, 2025 about Smart Comfort?

Resmed announced FDA clearance for Smart Comfort, an AI-enabled tool that recommends personalized CPAP comfort settings.

When will Resmed (RMD) launch the Smart Comfort beta and wider U.S. rollout?

A limited U.S. beta for new myAir users paired with AirSense 11 will begin early 2026, with a broader U.S. rollout later in 2026.

Which Resmed devices and apps support Smart Comfort at launch?

Smart Comfort will support new users of the myAir app paired with Resmed AirSense 11 devices at launch.

How does Smart Comfort personalize CPAP settings for RMD users?

It uses proprietary machine learning and >100 million nights of de-identified sleep data plus user info to recommend individualized comfort settings.

Does Smart Comfort change prescribed therapy settings for Resmed (RMD) patients?

No; Smart Comfort provides non-prescription comfort recommendations and does not alter prescribed therapy settings or efficacy.