ResMed announced that the U.S. Food and Drug Administration has granted clearance for its AI‑enabled Smart Comfort feature, a personalized comfort setting for CPAP devices, on December 8, 2025. The approval allows the company to launch Smart Comfort in the U.S. market in early 2026, initially in a limited beta version for new users of its myAir app paired with the AirSense 11 device.
Smart Comfort leverages ResMed’s proprietary machine‑learning algorithms trained on more than 100 million nights of de‑identified sleep data. The feature automatically recommends individualized comfort settings that help patients adjust to CPAP therapy more quickly and stay on treatment longer. The technology is designed for use with the AirSense 11 CPAP device and the myAir mobile app, which together provide a cloud‑connected ecosystem for data collection and patient coaching.
The FDA clearance is a key milestone in ResMed’s strategy to convert one‑time hardware sales into recurring digital‑health revenue. By offering a data‑driven, personalized experience, the company can deepen customer loyalty, increase device usage, and generate additional data that feeds its AI models. This aligns with ResMed’s broader goal of expanding its software‑centric business, which has already driven an 11% year‑over‑year revenue increase to $1.2 billion in Q1 FY2025 and a gross margin improvement of 420 basis points to 58.6%.
Chief Product Officer Justin Leong said, “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.” CEO Mick Farrell added that the company’s “ongoing momentum and strong execution across all areas of our business” underpins the confidence in its digital‑health expansion and the ability to maintain profitability while investing in AI.
The approval positions ResMed to maintain its dominant market share in the sleep‑apnea device market, where it holds an estimated 50‑60% share. Competitors such as Philips Respironics and Fisher & Paykel have faced product recalls and pricing pressure, creating opportunities for ResMed to capture additional market share. The company’s focus on AI and cloud connectivity, exemplified by Smart Comfort, is expected to drive long‑term growth and reinforce its competitive advantage.
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