Resmed believes its artificial intelligence-powered approach to personalizing the settings of its connected CPAP machines can lead to better sleep for people with obstructive apnea. Now the FDA has given it the green light.
The agency issued a 510(k) clearance to the company’s Smart Comfort program, which helps people start and stay on their therapy from the first night—tailoring air pressure as they inhale and exhale based on a user’s particular needs, as well as a machine learning model trained on more than 100 million recordings of real-world sleep.
“For people new to CPAP therapy, personalized comfort settings can help them adjust faster and more comfortably, improving confidence and overall health,” Resmed’s chief product officer, Justin Leong, said in a statement. “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.”
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The company submitted to the FDA retrospective, de-identified information gathered from its AirSense 10 and 11 machines, showing that—among users whose non-prescription settings matched what Smart Comfort would have recommended anyway—they had higher engagement and therapy adherence rates compared to the systems’ defaults.
Resmed estimates that about 61 million people in the U.S. have obstructive sleep apnea, which can increase the risks of heart disease, Type 2 diabetes and stroke if left untreated. The company expects that number to rise to nearly 77 million cases by the year 2050.
The ultimate goal is to streamline new user setup and reduce the number of manual adjustments needed at the start of therapy, when people are still tinkering with the mask fit and other issues.
Smart Comfort is set to launch in a limited beta in early 2026 for new users of Resmed’s myAir smartphone companion app and AirSense 11 hardware, with a broader rollout scheduled for later in the next year.
