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Intended Use

A software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. Intended for use by healthcare solution integrators to build applications allowing qualified professionals to review and confirm analytic results. Supports data recorded by FDA cleared arrhythmia diagnostic devices such as Holter and event recorders. Provides ECG signal processing, QRS and ventricular ectopic beat detection, interval and heart rate measurement, and rhythm analysis.

Technology

The device consists of a web application programming interface (API) that accepts digital ECG files securely and an automated proprietary algorithm that detects cardiac beats, arrhythmias, and intervals such as heart rate, RR intervals, and QRS complexes to provide supportive information for healthcare professionals via interpretation results.

Performance

Performance testing included sensitivity, specificity, predictive values validated against gold standards, software verification, and usability testing ensuring user ability to upload, review, and download. Software development and validation followed IEC 62304:2015 and FDA guidelines, classifying the software as a major level of concern. Testing met all requirements with no anomalies found.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/28/2018

    6 months
  • 2

    FDA Approval

    3/7/2019

Other devices from Biofourmis Singapore Pte. Ltd.

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