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Intended Use

Masimo W1 and the integrated Masimo W1 Module are intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The device detects the presence of atrial fibrillation and supports classification of either atrial fibrillation (AFib) or sinus rhythm for informational use only in adults 22 years and older. It is also intended for spot-checking of functional oxygen saturation (SpO2) and pulse rate (PR) in adults in hospitals, clinics, long-term care facilities, and homes.

Technology

Masimo W1 uses an integrated module combining electrical sensing for ECG and optical sensing (Masimo SET pulse oximetry) for SpO2 and pulse rate. ECG signals are detected via electrical contacts on the wrist and fingers and processed by software that analyzes rhythms, including atrial fibrillation detection based on pattern irregularity. The device communicates data wirelessly to compatible smart devices for display and tracking.

Performance

Performance evaluation includes clinical validation of the AFib classification feature showing 99.3% sensitivity and 100% specificity. The ECG waveform quality was validated against 12-lead ECG references with 98% clinician agreement. Bench, software verification, human factors, and cybersecurity testing support substantial equivalence and safety. No hardware changes were made from previous clearance.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/21/2024

    5 months
  • 2

    FDA Approval

    4/3/2025

Other devices from Masimo Corporation

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