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AI news ·

Masimo gets FDA clearance for AFib detection on Radius VSM

Masimo’s Radius VSM monitor got FDA clearance for a new feature that screens for atrial fibrillation using pulse waveforms, but it’s not a replacement for diagnostic tests.

1 min read
HealthcareInsuranceOperationsProduct development

Masimo has received FDA clearance for a new atrial fibrillation detection feature on its Radius VSM patient monitor. The software continuously analyzes pulse waveforms and flags rhythms that may require further review via ECG or telemetry.

Vendor validation data for the screening tool reported strong sensitivity and specificity. The clearance supports use of the feature as an adjunctive screening method, not as a replacement for diagnostic confirmation.

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