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

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

Key Figures

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

Market Reality Check

$256.55 Last Close

Volume Volume 700,990 is below the 20-day average of 997,455, indicating subdued trading activity before this news. normal

Technical Price at 256.55 was trading slightly above the 200-day MA 252.77, reflecting a modestly constructive longer-term trend.

Peers on Argus

RMD was up 2% while key peers showed small mixed moves (e.g., ALC -0.38%, SOLV +0.84%), suggesting the setup was more stock-specific than sector-driven ahead of this FDA clearance.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Oct 30	Earnings results	Positive	-0.5%	Strong Q1 2026 revenue, margin expansion, and EPS growth.
Oct 09	Earnings preview	Neutral	-2.1%	Announcement of upcoming Q1 2026 earnings release and webcast.
Sep 16	Conference participation	Neutral	-0.3%	Planned presentation at Bank of America Global Healthcare Conference.
Sep 03	Sleep initiative launch	Positive	+1.7%	Launch of Sleep Institute to advance global sleep health science.
Aug 27	OSA prevalence study	Positive	-1.1%	Study projecting large U.S. OSA burden and future growth.

Pattern Detected

Recent news often saw muted or negative price reactions, even to seemingly positive developments, with only one clear alignment between upbeat news and a positive move.

Recent Company History

Over the last few months, ResMed reported strong fiscal Q1 2026 results with $1.336B revenue and expanding margins, yet shares slipped slightly after earnings. Other corporate updates, including conference participation and launch of the Sleep Institute, produced modest price moves, with only the Sleep Institute news aligning clearly with a positive reaction of 1.71%. A major OSA prevalence study highlighted long-term demand drivers but saw a -1.13% move. Against this backdrop, FDA clearance for Smart Comfort adds another data-driven, product-focused milestone.

Market Pulse Summary

This announcement highlights FDA clearance for Smart Comfort, an AI-enabled CPAP comfort feature trained on over 100 million nights of real-world sleep data and aimed at improving adherence for people with obstructive sleep apnea. It extends ResMed’s connected ecosystem around AirSense 11 and myAir. In context of earlier studies projecting up to 77 million U.S. OSA cases by 2050, investors may watch adoption metrics, user engagement data, and integration with existing digital tools over 2026 rollouts.

Key Terms

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.

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-generated analysis. Not financial advice.

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

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.