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ResMed has revealed that it has obtained FDA clearance for its Smart Comfort personalized therapy solution.

The San Diego–based company describes Smart Comfort, which it submitted to the FDA under the name “Personalized Therapy Comfort Settings, or PTCS” as the first FDA-cleared, AI-enabled medical device designed to recommend individualized comfort settings to help people with obstructive sleep apnea (OSA) begin and maintain continuous positive airway pressure (CPAP) therapy.

ResMed expects to launch a limited U.S. beta release of Smart Comfort early next year, initially focusing on new users of the myAir consumer sleep companion app in combination with the AirSense 11 device. A wider U.S. rollout for new myAir users is planned for later in 2026.

The company notes that CPAP therapy varies by individual, with comfort and mask-fit concerns frequently affecting long-term adherence. Smart Comfort leverages proprietary machine learning models built from more than 100 million nights of real-world sleep data. Using de-identified details such as age, gender, and Apnea-Hypopnea Index (AHI), it generates personalized comfort recommendations.

These tailored settings are intended to help users adapt more easily to therapy by managing gradual pressure increases and reducing exhalation pressure.

To support its FDA application, ResMed submitted retrospective real-world evidence from AirSense 10 and 11 users. Individuals whose comfort settings aligned with Smart Comfort recommendations showed greater engagement and improved long-term adherence compared to those using default settings. The company says the results indicate that personalization can boost comfort without diminishing therapeutic effectiveness.

For clinicians, Smart Comfort aims to simplify both initial setup and ongoing follow-up by reducing the need for manual adjustments. This allows providers to dedicate more attention to clinical decision-making and patient support. The system also helps users feel more assured in their customized settings. Because the comfort settings are non-prescription, they enhance CPAP usability without changing prescribed therapy parameters or efficacy.

According to ResMed, Smart Comfort is part of its broader connected and personalized sleep health ecosystem, integrating AI, cloud-enabled devices, and digital tools to make sleep therapy more individualized and effective.

© ResMed