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Home » Masimo gets FDA nod for AI-enabled opioid-induced respiratory depression detection tech

Masimo gets FDA nod for AI-enabled opioid-induced respiratory depression detection tech

June 22, 2026 By Sean Whooley

Masimo Radius VS OIRD capability
The OIRD detection capability [Image courtesy of Masimo]
Masimo, a Danaher (NYSE:DHR) company, today announced FDA clearance for an opioid-induced respiratory depression (OIRD) detection platform.

Irvine, California-based Masimo — which became a part of Danaher through a $10 billion acquisition earlier this month — designed the capability for its Radius VSM wearable continuous patient monitor. Enabled by the next-generation smartSET pulse oximetry sensor platform, the feature uses advanced pattern recognition. It analyzes continuous physiologic data to help clinicians identify early signs of respiratory compromise in hospital patients receiving opioid therapy.

Radius VSM, a modular, wearable device, enables providers to equip any hospital bed with comprehensive monitoring. They can quickly add or remove measurement technologies to match each monitoring scenario, leading to more personalized care. The OIRD feature includes visual alarms, alerting clinicians to changing conditions as OIRD risk increases.

Masimo said this marks the first implementation of its OIRD detection capability in a hospital monitoring solution. It combines the SET pulse oximetry with AI-enabled analysis to expand the role of pulse oximetry. The platform translates continuous data into earlier clinical awareness, supporting faster, more informed decisions. Masimo also plans to develop further pattern-recognition algorithms for its smartSET platform.

According to the company, smartSET technology aims to unlock the value of continuous parameter insights. It analyzes complex physiological patterns and relationships, rather than relying on individual parameters alone. The design allows for future integration into additional hospital monitoring solutions.

Dr. Basil Matta, chief medical officer at Masimo, 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.”

Filed Under: 510(k), Artificial Intelligence (AI), Diagnostics, Digital Health, Food & Drug Administration (FDA), Health Technology, Hospital Care, Machine Learning (ML), Patient Monitoring, Regulatory/Compliance, Respiratory, Software / IT Tagged With: danaher, Danaher Corp., FDA, Masimo

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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