FDA Clears New Masimo Monitoring Feature

▤ Summary

Masimo received FDA 510(k) clearance for a new monitoring feature that detects opioid-induced respiratory depression in hospital patients. The capability uses AI-enabled analysis and runs on the company’s Radius VSM wearable continuous patient monitor. This is the first hospital monitoring implementation of Masimo’s OIRD detection technology. The approval strengthens Masimo’s clinical monitoring portfolio shortly after its move into Danaher’s diagnostics segment.

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Masimo

$1B+