ResMed Inc. has received U.S. Food and Drug Administration (FDA) clearance for its Personalized Therapy Comfort Settings, which will be marketed as Smart Comfort. This AI-enabled digital medical device is designed to personalize CPAP therapy for individuals with obstructive sleep apnea, using real-world sleep data and machine learning to optimize comfort settings. Smart Comfort is the first FDA-cleared AI device to recommend individualized comfort settings for CPAP therapy and will be launched in early 2026 in a limited U.S. beta version for new users of the myAir app paired with the ResMed AirSense 11 device, with a broader rollout planned later in the year.