Speciality diagnostics solutions developer Masimo has received 510(k) clearance from the US Food and Drug Administration (FDA) for an opioid-induced respiratory depression (OIRD) detection feature integrated into the Radius VSM patient monitor.
The newly cleared capability uses AI via the smartSET pulse oximetry sensor platform, which is designed to support clinicians in identifying early signs of respiratory compromise among hospital patients treated with opioid medication.
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This marks the first time Masimo has implemented OIRD detection within a hospital monitoring solution.
The system applies advanced pattern recognition to continuous physiological data, with the aim of helping clinical staff recognise early changes in respiratory status during opioid therapy.
SmartSET analyses combine with the existing Masimo SET signal quality to translate ongoing data into earlier clinical awareness.
Masimo stated that additional pattern-recognition algorithms are in development for the smartSET platform, with the intention to extend its use across wider patient-care scenarios within the hospital.
Visual alarms are included as part of the OIRD feature, alerting clinicians to potential changes in a patient’s condition and escalating as risk levels increase.
These alerts are displayed on the Radius VSM device and can also be transmitted to remote and centralised monitoring stations.
Masimo chief medical officer Dr Basil Matta said: “Opioid-induced respiratory depression remains a critical patient-safety concern. With OIRD detection, Masimo is bringing advanced pattern recognition to continuous, wearable monitoring to help clinicians identify earlier changes in a patient’s respiratory status that may not be apparent through traditional approaches.
“This capability reflects our ongoing focus on working closely with clinicians to address complex patient-safety challenges with meaningful innovation. OIRD detection on Radius VSM will help expand continuous monitoring from simple measurement to meaningful insight, supporting safer care throughout the hospital.”
The Radius VSM is described as a modular device designed for continuous patient assessment, with monitoring that can be tailored to the individual.
Masimo indicates the technology will support expanded clinical use beyond simple measurements by integrating smartSET-powered physiological insight into more hospital care areas.
In September 2025, Philips and Masimo renewed a longstanding strategic partnership to develop patient care solutions.
