Resmed Receives FDA Clearance for Smart Comfort Device
Resmed announced it has received U.S. Food and Drug Administration, FDA, clearance for Personalized Therapy Comfort Settings, PTCS, to be marketed as Smart Comfort. Smart Comfort is the first FDA-cleared 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.
