RMD Stock Set to Gain From FDA Clearance of AI-Enabled Smart Comfort

Resmed RMD has received FDA clearance for Personalized Therapy Comfort Settings (“PTCS”), which will be marketed as Smart Comfort. The company will debut Smart Comfort 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, and will be followed by a broader U.S. rollout to new myAir users later in 2026.

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. 

RMD Stock Outlook Following the News

After the announcement yesterday, shares of Resmed dropped 2.5%, finishing the session at $250.04. Meanwhile, an estimated 61 million U.S. people have obstructive sleep apnea (OSA), a number projected to reach nearly 77 million by 2050. Left untreated, it increases the risk of high blood pressure, heart disease, type 2 diabetes and stroke. CPAP therapy can significantly reduce the risk of death in people with OSA. Resmed’s Smart Comfort is the first FDA-cleared AI-enabled medical device that recommends personalized comfort settings to help people with OSA start and maintain CPAP therapy. Accordingly, the news should help support a rebound in RMD stock performance. 

Resmed presently boasts a market capitalization of $37.44 billion. The Zacks Consensus Estimate for the company’s fiscal 2026 earnings suggests a 13.2% increase. In the trailing four quarters, it delivered an earnings beat of 3%, on average.

More on Resmed’s Smart Comfort

Since CPAP therapy is not one-size-fits-all, tackling 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 the company’s 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.

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.

For healthcare providers, Smart Comfort offers a solution to help streamline user setup and follow-up and reduce manual adjustments so that clinicians can devote more attention to clinical decision-making and patient support. 

Industry Prospects Favoring RMD

According to Precedence Research, the global sleep apnea device market is valued at $7.11 billion in 2025 and is expected to witness a compound annual growth rate of 7% through 2034. Factors like the rising prevalence of sleep apnea, the rapidly expanding medical device sector and technological advancements are boosting the market’s growth.

Other Developments at Resmed

In September, Resmed launched Sleep Institute, a global clinical insights initiative dedicated to advancing the science and understanding of sleep health. It partners with clinicians, researchers, policymakers and health system leaders to deliver objective, non-commercial, evidence-based insights that help inform care innovation, support policy decisions and elevate sleep as a global health priority.

RMD Stock Price Performance

Year to date, Resmed shares have rallied 9.3% compared with the industry’s rise of 3.2%.

RMD’s Zacks Rank and Key Picks

Resmed currently carries a Zacks Rank #3 (Hold).

Some other top-ranked stocks in the broader medical space are BrightSpring Health Services BTSG, Illumina ILMN and Omnicell OMCL. While BrightSpring and Illumina eachsport a Zacks Rank #1 (Strong Buy), Omnicell carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Estimates for BrightSpring Health Services’ 2025EPS have increased 5.7% in the past 30 days. Shares of the company have surged 92.3% in the past year compared with the industry’s 1.1% growth. BTSG’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 45.1%. In the last reported quarter, it delivered an earnings surprise of 11.1%.  

Illumina shares have fallen 9.4% in the past year. Estimates for the company’s 2025 EPS have risen 0.9% to $4.71 in the past 30 days. ILMN’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, delivering an average surprise of 6.7%. In the last reported quarter, it posted an earnings surprise of 15.5%.

Omnicell shares have dropped 13.9% in the past year. Estimates for the company’s 2025 EPS have increased 8.3% to $1.70 in the past 30 days. OMCL’s earnings topped estimates in each of the trailing four quarters, delivering an average surprise of 38.7%. In the last reported quarter, it posted an earnings surprise of 41.7%.

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This article originally published on Zacks Investment Research (zacks.com).

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