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BUSINESS · JUN 28, 2026
FDA Clears Masimo Opioid Respiratory Depression Detection Tool
Masimo received FDA clearance for a wearable monitor feature that detects opioid-induced respiratory depression to help clinicians identify early signs of patient compromise.
The Food and Drug Administration granted 510(k) clearance on June 22 for an opioid-induced respiratory depression detection capability integrated into the Radius VSM wearable continuous patient monitor. Developed by Masimo, the feature utilizes the smartSET pulse oximetry sensor platform and advanced pattern recognition to enable clinicians to identify early signs of respiratory compromise in patients undergoing opioid therapy.
Reported across 2 outlets
Actors
Food and Drug AdministrationMasimo
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