Newly cleared Resmed Smart Comfort uses real-world sleep data and machine-learning algorithms to recommend individualized comfort settings for AirSense 11 users, aiming to boost engagement and adherence.
Key takeaways:
- Smart Comfort received FDA 510(k) clearance and will debut in early 2026 as a limited US beta for new myAir users paired with AirSense 11.
- The tool personalizes non-prescription comfort settings using machine-learning models trained on more than 100 million nights of de-identified sleep data.
- Retrospective evidence showed higher engagement and sustained adherence among users whose settings aligned with Smart Comfort recommendations.
- The system is intended to support therapy use—not modify prescribed therapeutic pressure settings or efficacy.
- Clinicians may see reduced manual adjustments and simplified setup workflows, allowing more focus on clinical care.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Personalized Therapy Comfort Settings to be marketed by Resmed as Smart Comfort.
Smart Comfort is an FDA-cleared artificial intelligence (AI)-enabled medical device developed by Resmed that recommends personalized comfort settings to help people with obstructive sleep apnea (OSA) start and stay on CPAP therapy. It will launch in early 2026 in a limited US 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 US rollout to new myAir users later in 2026.
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 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.
“For people new to CPAP therapy, personalized comfort settings can help them adjust faster and more comfortably, improving confidence and overall health,” says Justin Leong, chief product officer at Resmed, in a release. “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.
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.
