Resmed has earned U.S. Food and Drug Administration (FDA) clearance for Personalized Therapy Comfort Settings (PTCS), to be marketed as Smart Comfort.

According to the company, Smart Comfort is the first FDA-cleared, artificial intelligence (AI)-enabled medical device that recommends personalized comfort settings to help people with obstructive sleep apnea (OSA) start and remain on CPAP therapy. It will launch in early 2026 in a limited U.S. beta version for new users of Resmed’s myAir consumer sleep companion app, paired with an AirSense 11 device.

This will be followed by a broader U.S. release to new myAir users later in 2026.

Smart Comfort uses Resmed’s machine learning algorithms, which draw on over 100 million nights of de-identified, real-world sleep data and user information like age, gender, and Apnea-Hypopnea Index (AHI) to recommended individualized comfort settings for CPAP therapy from AirSense 11 devices. The settings can help users ease into therapy, adjust the rate an AirSense 11 increases pressure and reduce pressure on exhale.

“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 show 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.

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