Resmed (NYSE: RMD) has received clearance from the U.S. Food & Drug Administration (FDA) for its Personalized Therapy Comfort Settings (PTCS) device to support people with obstructive sleep apnea who are using CPAP therapy.
The device, which incorporates artificial intelligence (AI), will be marketed as Smart Comfort and will launch as a limited beta version in the United States in early 2026, Resmed said in a Dec. 8 announcement. Smart Comfort is aimed at new users of myAir, Resmed’s consumer sleep companion app, in conjunction with Resmed’s AirSense 11 device.
“Smart Comfort is the first FDA-cleared AI-enabled medical device that recommends personalized comfort settings to help people with obstructive sleep apnea start and stay on CPAP therapy,” Resmed said. “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.”
Resmed added that it supplied the FDA with “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.”
Resmed added that Smart Comfort also supports health care providers as “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.”
“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, Resmed’s chief product officer. “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.”
