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Intended Use

Intended to be used with continuous biometric data from cleared sensors measuring heart rate, respiratory rate, and activity in ambulatory patients during minimal activity periods, to generate a Biovitals Index reflecting changes from individualized biometric baseline for routine monitoring, not for diagnostic use or treatment decisions; intended for adult patients.

Technology

A cloud-based software system that uses an automated proprietary algorithm to analyze continuous physiological data streams, creating a dynamic individualized biometric signature and calculating a time series Biovitals Index representing deviations from baseline, with data storage and retrieval via secure web APIs and visualization through a web dashboard for clinician review.

Performance

Verification and validation testing confirmed all design input requirements and product specifications without residual anomalies. Software underwent usability testing, and clinical testing with 50 emergency department patients showed the Biovitals Index correlated well with expert physician assessments of vital sign changes, establishing substantial equivalence to the predicate device.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/26/2018

    8 months
  • 2

    FDA Approval

    8/15/2019

Other devices from Biofourmis Singapore Pte. Ltd

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