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.
RT’s Three Key Takeaways:
- FDA Clearance – Resmed received FDA clearance for Smart Comfort, the first Ai-enabled medical device to recommend personalized comfort settings to help patients with obstructive sleep apnea start and stay on CPAP therapy.
- Personalized, Data-Driven Care – Smart Comfort uses machine-learning algorithms trained on more than 100 million nights of real-world sleep data to tailor non-prescription CPAP comfort settings without altering prescribed therapy.
- Improved Adherence and Workflow – Real-world evidence showed higher engagement and sustained CPAP adherence with Smart Comfort–aligned settings, while also helping clinicians streamline setup and follow-up.
Resmed received US FDA clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort, according to a company news release.
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 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.
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.
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.
