Resmed
(NYSE: RMD)
announced today that it received FDA clearance for its Smart Comfort personalized therapy offering.
San Diego–based Resmed calls Smart Comfort (which was submitted to the FDA as “Personalized Therapy Comfort Settings, or PTCS) the first FDA-cleared, AI-enabled medical device that recommends personalized comfort settings, helping people with obstructive sleep apnea (OSA) start and stay on continuous positive airway pressure (CPAP) therapy.
The company plans to begin rolling out a limited U.S. beta version of Smart Comfort early next year. It initially targets new users of the myAir consumer sleep companion app, paired with the AirSense 11 device. Then, Resmed plans for a broader U.S. rollout to new myAir users later in 2026.
According to Resmed, CPAP therapy is not one-size-fits-all, with common issues like comfort and mask fit promoting long-term adherence. Smart Comfort uses the company’s proprietary machine learning algorithms, drawing on more than 100 million nights of real-world sleep data. It uses de-identified information like age, gender and Apnea-Hypopnea Index (AHI) to recommend individualized settings.
Individualized settings can help users ease into therapy and adjust gradual pressure increases while reducing pressure on exhale.
Read more about Resmed’s ‘digital revolution’ in a recent MassDevice interview with CEO Mick Farrell.
Resmed supported its FDA submission with retrospective real-world evidence from users of the AirSense 10 and 11. Users with comfort settings that matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings.
According to Resmed, findings demonstrated that personalized comfort adjustments can help improve therapy without compromising efficacy.
For healthcare providers, Smart Comfort helps streamline user setup and follow-up while reducing manual adjustments. It helps clinicians devote more time and attention to decision-making and patient support. The technology also helps users build confidence in their personalized settings. Non-prescription comfort settings help support CPAP usage wihtout altering prescribed settings or efficacy.
Resmed said Smart Comfort comes as part of its connected, personalized sleep health ecosystem. It combines AI, cloud-connected devices and digital tools to make sleep health more personal and support therapy efficacy.
“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.”
