RMD Stock Set to Gain From FDA Clearance of AI-Enabled Smart Comfort

Core Insights - Resmed has received FDA clearance for its Personalized Therapy Comfort Settings (PTCS), branded as Smart Comfort, set to launch in early 2026 for new users of the myAir app paired with the AirSense 11 device [1][9] - Smart Comfort is designed to enhance the user experience in CPAP therapy by utilizing AI and real-world sleep data to provide personalized comfort settings [2][5] Company Developments - Resmed's Smart Comfort is the first FDA-cleared AI-enabled medical device that recommends personalized comfort settings for patients with obstructive sleep apnea (OSA), which affects an estimated 61 million people in the U.S. [3][9] - The company currently has a market capitalization of $37.44 billion, with a projected 13.2% increase in fiscal 2026 earnings according to the Zacks Consensus Estimate [4] Product Features - Smart Comfort addresses common therapy issues such as comfort and mask fit, promoting long-term adherence to CPAP therapy by leveraging machine-learning algorithms and over 100 million nights of de-identified sleep data [5][6] - The device settings include features that ease users into therapy, adjust pressure gradually, and reduce pressure on exhalation, developed with clinical oversight and ethical data use [6][7] Market Outlook - The global sleep apnea device market is valued at $7.11 billion in 2025, with a projected compound annual growth rate of 7% through 2034, driven by the rising prevalence of sleep apnea and advancements in medical technology [11] - Resmed's recent initiatives, such as the launch of the Sleep Institute, aim to advance the science of sleep health and support policy decisions [12] Stock Performance - Following the announcement of Smart Comfort, Resmed's shares dropped 2.5%, closing at $250.04, but the product is expected to support a rebound in stock performance [3] - Year-to-date, Resmed shares have increased by 9.3%, outperforming the industry average of 3.2% [13]