Resmed Receives FDA Clearance For AI-Enabled Features: What Does This Mean for You as a CPAP User?

March 9, 2026 |

Authored by

Key Takeaways

Smart Comfort receives FDA approval and is debuting in 2026.
The CPAP equipment personalizes non-prescription comfort settings.
Clinicians may see reduced manual adjustments, allowing more time to focus on clinical care.

Consistent CPAP therapy¹ has changed many lives. However, for many CPAP users, it can be challenging to find the perfect settings. Resmed just took a huge step toward making the process easier. The company recently announced FDA clearance for an AI-enabled feature called Smart Comfort. This feature is designed to adjust comfort settings based on the user’s real sleep data and machine learning.

This isn’t just a convenient app feature. It’s a first-of-its-kind AI-enabled medical device that can potentially help CPAP users start and stay on therapy comfortably.

What is Resmed's New "Smart Comfort" Feature?

Smart Comfort, officially called Personalized Therapy Comfort Settings (PTCS), and it’s an AI-driven tool designed to recommend personalized comfort settings for CPAP therapy. The premise is to support users during the setup and early stages of their therapy by recommending optimal non-prescriptions settings. For example, it may suggest settings such as ramp timing or exhalation relief. These suggested settings will be based on sleep data and individual characteristics.

Smart Comfort is not intended to alter prescribed therapeutic pressure. Instead, it focuses on enhancing user comfort. The goal is to help users feel more at ease with their therapy from their first night.

How it Works

Let’s look at how the Smart Comfort device works, and how it can help users achieve the best results from CPAP therapy.

AI and Data Driven

Smart Comfort uses machine learning models that have been trained using millions of nights of real sleep data. The algorithms analyze patterns across user data. It will consider factors like age, gender and Apnea-Hypopnea Index (AHI)², to determine comfort settings that are likely to work best.

This data-driven approach provides a better foundation by going beyond generic presets that most CPAP users are familiar with. What does this mean for the average CPAP user? It means instead of a one-size-fits-all comfort profile, users get specific recommendations informed by patterns observed across a very broad user base.

More Personalized Settings for Enhanced Comfort

Smart Comfort can help users adjust settings that influence how their therapy feels. It can suggest things like:

Ramp speed and start pressure. This eases you into pressure instead of giving it to you all at once.
Exhalation relief tweaks. By reducing pressure during exhales, users can enjoy a more natural breathing experience.

Personalized suggestions like these can make a noticeable difference, especially for new users who are still trying to adjust to CPAP use.

Seamless Integration and Streamlined Setup

Smart Comfort is designed to work with Resmed’s connected ecosystem. It is easy to integrate with the myAir app and also pairs with other compatible Resmed devices like the AirSense 11. This means that there aren’t a lot of separate tools needed. Comfort personalization is simply part of setting up the device and the user’s ongoing experience.

Being able to streamline adjustments, especially with early use, helps users feel more comfortable quickly³, but it can also reduce the need for numerous manual tweaks and repeated calls to support.

Shop AirSense 11

What Does This Mean for CPAP Users?

The FDA-cleared Smart Comfort provides several potential benefits for CPAP users.

Easier adjustments for new users. Everything can feel overwhelming when first starting CPAP therapy. Being able to get personalized comfort suggestions right away can help you settle into therapy faster while reducing frustration.
Better therapy experience. Comfort influences how consistently CPAP therapy is used. Having more tailored settings might translate to better long-term adherence, which provides better sleep outcomes.
Support without prescription changes. Smart Comfort provides optional suggestions for users to try. It does not change your prescribed therapeutic pressure or compromise the effectiveness of your treatment.
Clinician support. The feature is mostly user-facing, but it can also be useful for clinicians by helping them streamline the setup and follow-up. This can reduce the need for manual adjustments and provide free time for clinicians to address other care needs.

Where to Buy Resmed Products Online

Interested in experiencing Resmed devices with advanced comfort features? You’ll find a wide selection of Resmed AirSense 11 CPAP machines, masks, and accessories at The CPAP Shop. Whether you are starting CPAP therapy, or upgrading your current setup, The CPAP Shop offers Resmed products and helpful support to ensure you get the best fit and the most comfortable sleep possible. For more information, contact out expert customer care team at 866-414-9700.

References

National Center for Biotechnology Information. Obstructive Sleep Apnea and Intermittent Hypoxia: Pathophysiology and Clinical Implications (PMC5436801). PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC5436801/
Cleveland Clinic. Apnea-Hypopnea Index (AHI). my.clevelandclinic.org. https://my.clevelandclinic.org/health/articles/apnea-hypopnea-index-ahi
WebMD. Managing CPAP Discomfort. WebMD Sleep Disorders Center. https://www.webmd.com/sleep-disorders/sleep-apnea/cm/managing-cpap-discomfort

Share this Post

Chris Vasta

Chris Vasta is the president of The CPAP Shop and an expert in sleep and respiratory therapy. He often provides insights on product design and functionality on various manufacturers’ prototypes and is frequently tapped to provide reviews on new releases.