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RegulationJune 23, 2026

Masimo secures FDA approval for OIRD detection on wearable patient monitor

Masimo received FDA 510(k) clearance for an opioid-induced respiratory depression (OIRD) detection feature on its Radius VSM wearable patient monitor. The clearance enables the device to detect and alert clinicians to respiratory depression associated with opioid use in monitored patients.

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