Resmed’s Smart Comfort Receives FDA Approval for Apnea Therapy

SAN DIEGO—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 artificial intelligence (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 United States 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.

“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, chief product officer at Resmed. “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.”