FDA-Cleared AI Wearable Monitor Detects Opioid-Related Respiratory Risk in Hospitals

Continuous wearable monitoring with pattern-recognition capabilities can help clinicians identify worsening physiology sooner. A new AI-enabled wearable vital signs monitor is designed to detect opioid-induced respiratory depression and support earlier bedside intervention.

Masimo, a Danaher company specializing in pulse oximetry and patient monitoring technologies, has received FDA 510(k) clearance for an opioid-induced respiratory depression (OIRD) detection capability integrated into its Radius VSM wearable, tetherless vital signs monitor. The clearance marks the first use of Masimo’s OIRD detection technology in a hospital monitoring solution. Powered by the next-generation smartSET platform, the feature builds on the signal quality of Masimo SET pulse oximetry to help identify respiratory risk in monitored patients.

The pattern‑recognition capability analyzes continuous physiologic data to surface earlier signs of respiratory compromise in patients receiving opioid therapy. Built on RD SET sensor technology, smartSET is engineered to evaluate complex physiological patterns and relationships rather than relying on individual parameters alone. With the addition of smartSET analysis and OIRD detection, Radius VSM expands its ability to assist clinicians in spotting changes in patient condition across care areas.

The OIRD feature provides visual alarms that escalate as risk increases, displayed on the device and relayed to remote or centralized monitoring stations. Translating continuous data into earlier clinical awareness is intended to support faster, more informed decisions when time is critical, including periods of rapid deterioration. The smartSET design also allows integration into additional hospital monitoring solutions within a connected ecosystem.