Irvine, Calif. — Masimo has received U.S. Food and Drug Administration 510(k) clearance for an AI-enabled feature designed to help clinicians detect opioid-induced respiratory depression in hospitalized patients.
The detection capability is integrated into Masimo’s Radius VSM wearable continuous patient monitor and powered by the company’s smartSET pulse oximetry sensor platform. It uses pattern recognition to analyze continuous physiological data and identify early signs of respiratory problems in patients receiving opioid therapy.
Masimo, a Danaher company, said the clearance marks the first use of its opioid-induced respiratory depression detection technology in a hospital monitoring system.
“Opioid-Induced Respiratory Depression remains a critical patient-safety concern,” said Dr. Basil Matta, Chief Medical Officer at Masimo. “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 smartSET platform builds on Masimo’s RD SET sensor technology and evaluates patterns and relationships across physiological data rather than relying on individual measurements alone. Masimo is also developing additional pattern-recognition algorithms for the platform.
Radius VSM is a wearable, wireless and modular vital-signs monitor designed for continuous patient monitoring throughout a hospital. Its monitoring capabilities can be adjusted based on an individual patient’s needs.
The newly cleared feature includes visual alarms that notify clinicians about changes in a patient’s condition and escalate as the risk of opioid-induced respiratory depression increases. Alerts can be displayed on the device and transmitted to remote or centralized monitoring stations.
Masimo said the technology is intended to provide clinicians with earlier insight into respiratory risk, supporting faster decisions when a patient’s condition begins to deteriorate.
