Resmed said it has received FDA clearance for an 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 U.S. 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 U.S. rollout to new myAir users later in 2026.
It 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. The settings should help ease users into therapy, adjust how gradually an AirSense 11 increases pressure and reduce pressure on exhale.
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.
