ResMed Secures FDA Clearance for AI-Enabled Smart Comfort CPAP Device

Reuters12-08 22:00

ResMed Secures FDA Clearance for AI-Enabled Smart Comfort CPAP Device

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. ResMed Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9597993-en) on December 08, 2025, and is solely responsible for the information contained therein.

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