ResMed(US:RMD) Globenewswire·2025-12-08 14:00Core Insights - Resmed has received FDA clearance for its AI-enabled medical device, Smart Comfort, aimed at improving CPAP therapy adherence for patients with obstructive sleep apnea (OSA) [1][2][4] Group 1: Product Overview - Smart Comfort is the first FDA-cleared device that recommends personalized comfort settings for CPAP therapy, launching in early 2026 in a limited U.S. beta version [2] - The device utilizes machine-learning algorithms based on over 100 million nights of de-identified sleep data to tailor comfort settings for users [3] - Smart Comfort aims to address common therapy issues such as comfort and mask fit, promoting long-term adherence to CPAP therapy [3] Group 2: Clinical and Market Impact - The FDA submission was supported by evidence showing that users whose comfort settings matched Smart Comfort recommendations had higher engagement and sustained therapy adherence compared to those using default settings [4] - OSA affects an estimated 61 million people in the U.S., projected to rise to nearly 77 million by 2050, highlighting a significant market opportunity for Resmed [5] - CPAP therapy is recognized as the gold standard treatment for sleep apnea, significantly reducing health risks associated with untreated OSA [5] Group 3: Benefits for Healthcare Providers - Smart Comfort streamlines user setup and follow-up for healthcare providers, allowing clinicians to focus more on clinical decision-making and patient support [6] - The device helps standardize comfort settings, enhancing user confidence that their therapy is personalized [6] Group 4: Company Vision and Commitment - Smart Comfort is part of Resmed's broader connected, personalized sleep-health ecosystem, which integrates AI and cloud-connected devices to enhance therapy efficacy [7] - Resmed is committed to responsible, data-driven innovation to improve sleep health and empower users [8]