June 22, 2026- Masimo announced FDA 510(k) clearance for an opioid-induced respiratory depression detection capability integrated into the Radius VSM® wearable continuous patient monitor. Enabled by Masimo’s next-generation smartSET™ pulse oximetry sensor platform, the new feature uses advanced pattern recognition that analyzes continuous physiologic data to help clinicians identify early signs of respiratory compromise in hospital patients receiving opioid therapy.
This clearance represents the first implementation of Masimo’s OIRD detection capability in a hospital monitoring solution. By combining the trusted signal quality of best-in-class Masimo SET® with AI-enabled analysis, smartSET features like OIRD detection are expanding the role of pulse oximetry from monitoring patient status to surfacing actionable insights. Translating continuous data into earlier clinical awareness supports faster, more informed decisions when time matters most, such as when a patient’s condition is rapidly worsening. To accelerate the potential impact of such technology on how patient care is delivered throughout the hospital, Masimo is developing additional pattern-recognition algorithms for the smartSET platform.