Resmed receives FDA clearance for AI-enabled CPAP settings 

SAN DIEGO – Resmed has received clearance from the U.S. Food and Drug Administration (FDA) for an artificial intelligence (AI)-enabled device that recommends personalized comfort settings to help people with obstructive sleep apnea (OSA) start and stay on CPAP therapy.  

Personalized Therapy Comfort Settings (PTCS), which will be marketed as Smart Comfort, will launch in early 2026 in a limited beta version in the United States for new users of myAir paired with AirSense 11, followed by a broader rollout later in 2026. 

“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.” 

Resmed says 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.  

Why is Smart Comfort needed 

Resmed says addressing common therapy issues, like comfort and mask fit, early can promote long-term adherence. Smart Comfort leverages the company'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 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.  

What it means for providers 

Resmed says 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.