Masimo CorporationFDA clearance for AI-powered opioid respiratory depression detection on Radius VSM

Masimo has received FDA 510(k) clearance for an opioid-induced respiratory depression detection capability integrated into its Radius VSM wearable continuous patient monitor. The new feature, powered by Masimo's next-generation smartSET pulse oximetry sensor platform, uses advanced pattern recognition to analyze continuous physiologic data and help clinicians identify early signs of respiratory compromise in hospital patients receiving opioid therapy. This clearance marks the first implementation of Masimo's OIRD detection capability in a hospital monitoring solution, expanding the role of pulse oximetry from monitoring patient status to surfacing actionable insights. The OIRD feature includes visual alarms that escalate as risk increases, with alerts displayed on the device and relayable to remote monitoring stations. Masimo is developing additional pattern-recognition algorithms for the smartSET platform to extend its impact across care environments.
Masimo CorporationFDA clearance for AI-powered opioid respiratory depression detection on Radius VSM
Danaher Corporation