Andrew Goodwin

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Masimo gets FDA clearance for AFib detection on its smartSET pulse oximetry platform

Leading the INSPIRE trial feasibility study on pulse oximetry accuracy across skin tones

Masimo's smartSET pulse oximetry platform now detects atrial fibrillation, its second AI-powered clinical event feature after opioid-induced respiratory depression. The company announced the FDA clearance on October 17, 2026. In validation testing, the AFib feature detected suspicious rhythms with 97% sensitivity and 100% specificity.

Updated Oct 18