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Tuesday, Jun 23, 2026

FDA Clears New Masimo Monitoring Feature

Designed to detect opioid-induced respiratory depression in hospital patients

Masimo yesterday announced that it received FDA 510(k) clearance for a new monitor feature to detect breathing problems in patients receiving opioid therapy.

Masimo designed the new capability, which uses AI-enabled analysis, for its Radius VSM wearable continuous patient monitor.

The clearance marks the first implementation of Masimo’s opioid-induced respiratory depression (OIRD) detection technology in a hospital monitoring solution, according to the company.

It’s the most recent approval for the company since it became a part of Danaher’s diagnostics segment through a $9.9 billion acquisition this month.

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Yuika Yoshida
Yuika Yoshida
Yuika Yoshida has been a reporter covering healthcare, innovation and education at the Orange County Business Journal since 2023. Previous bylines include JapanUp! Magazine and Stu News Laguna. She received her bachelor's degree in literary journalism from the University of California, Irvine. During her time at UC Irvine, she was the campus news editor for the official school paper and student writer for the Samueli School of Engineering. Outside of writing, she enjoys musical theater and finding new food spots within Orange County.

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