Masimo Wins FDA Nod for Opioid-Induced Respiratory Depression Detection

▤ Summary

Masimo received FDA 510(k) clearance for an opioid-induced respiratory depression detection feature in its Radius VSM wearable patient monitor. The feature uses the company’s smartSET pulse oximetry platform and pattern-recognition analysis to spot early signs of respiratory compromise in hospital patients on opioid therapy. Masimo says the capability expands pulse oximetry from basic monitoring into actionable clinical insight. The company is also building additional algorithms for the smartSET platform and plans to extend the technology into more hospital monitoring products.

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Masimo

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