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Date: December 8, 2025 | Topic: CPAP Technology / ResMed News / CPAPeuropa
In a major leap forward for personalized sleep medicine, ResMed (NYSE: RMD) announced today that it has secured FDA clearance for its innovative Smart Comfort feature. This marks a historic moment in the industry, as Smart Comfort becomes the first FDA-cleared medical device utilizing Artificial Intelligence (AI) to automate and personalize therapy comfort settings for patients with Obstructive Sleep Apnea (OSA).
For millions of sleep apnea patients worldwide, this development promises to solve one of the biggest hurdles in CPAP therapy: getting comfortable enough to stick with it.
What is ResMed Smart Comfort?
Smart Comfort is a sophisticated feature integrated into ResMed’s ecosystem, specifically targeting the AirSense 11 auto-adjusting series and the consumer-facing myAir™ application.
The primary goal of this AI-driven tool is to move away from the traditional “one-size-fits-all” approach to CPAP configuration. Instead of relying on static default settings, Smart Comfort analyzes a vast array of data points to recommend or automatically adjust settings to match the specific needs of the individual user.
How the AI Engine Works
ResMed’s proprietary machine-learning algorithms power Smart Comfort. The technology is built upon an incredibly deep dataset, drawing insights from over 100 million nights of de-identified real-world sleep data.
By analyzing demographic information—such as age and gender—alongside clinical metrics like the Apnea-Hypopnea Index (AHI), the AI creates a personalized comfort profile.
Specifically, the AI adjusts non-prescription comfort settings to ease the transition into therapy. These adjustments typically involve:
- Ramp Time: Optimizing how gently the pressure increases as the user falls asleep.
- Expiratory Pressure Relief (EPR): Reducing pressure precisely during exhalation to make breathing against the machine feel more natural.
Bridging the Gap in Therapy Adherence
It is a well-known fact in the sleep medicine community that long-term health outcomes depend on adherence. However, issues with mask fit, pressure intolerance, and general discomfort often lead new users to abandon therapy within the first few months.
ResMed supported its FDA submission with strong retrospective evidence gathered from users of the AirSense 10 and AirSense 11 devices. The data revealed a compelling correlation: users whose machine settings aligned with the AI’s Smart Comfort recommendations demonstrated significantly higher engagement and sustained adherence to their therapy compared to those remaining on factory default settings.
Importantly, the findings proved that enhancing comfort via these AI adjustments helps users sleep better without compromising the clinical efficacy of the prescribed air pressure.
A Win for Clinicians and Patients
While Smart Comfort empowers patients to feel more confident in their therapy, it also offers substantial benefits to healthcare providers and sleep clinics.
By automating the optimization of comfort settings, the technology reduces the need for manual troubleshooting and follow-up appointments dedicated solely to comfort tweaks. This streamlining allows clinicians to devote more time to complex decision-making and supporting high-risk patients.
“For people new to CPAP therapy, personalized comfort settings can help them adjust faster and more comfortably, improving confidence and overall health. 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.”
— Justin Leong, Chief Product Officer at ResMed
What’s Next for ResMed Smart Comfort?
Following this FDA clearance, ResMed has outlined a phased rollout for the United States:
- Early 2026: A limited beta release targeting new users of the AirSense 11 and myAir app.
- Late 2026: A broader rollout to new users across the U.S.
While this announcement currently pertains to the US market, FDA clearance often paves the way for similar regulatory approvals in Europe and other global markets. At CPAPeuropa, we anticipate these features will eventually become standard for AirSense 11 users worldwide.
The Future of Sleep is Connected
This clearance underscores ResMed’s “digital revolution” strategy. By combining cloud-connected devices with AI, the company is transforming sleep health from a passive treatment into an active, personalized health ecosystem.
Stay tuned to CPAPeuropa.com for updates on when these new AI capabilities will become available for devices in Europe.
