PanopticAI Vital Signs
PanopticAI Technologies LimitedPanopticAI Vital Signs is a medical software application that uses AI algorithms to measure pulse rate non-invasively by analyzing color changes in facial video captured from an iPhone or iPad camera. It helps healthcare professionals monitor a patient's pulse rate remotely, providing a convenient tool to complement traditional vital sign assessments.
Intended Use
The PanopticAI Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still using facial video captured from a specified smartphone or tablet camera, for use by healthcare professionals in healthy subjects aged 18 to 60 who do not require critical or continuous monitoring.
Technology
The device uses remote photoplethysmography (rPPG) by capturing subtle color changes in the skin due to blood vessel light absorption via the front camera of an iPhone or iPad. RGB data are sent to a proprietary cloud-based algorithm service, which analyzes it to compute pulse rate and returns the result to the app without storing personal identifiable information.
Performance
Performance tests included software verification, usability, cybersecurity, and bench tests showing consistent accuracy independent of glasses, make-up, distance, facial hair, luminosity, and heart rate range. Clinical validation with 107 subjects demonstrated high accuracy and consistency across demographics and conditions, with results comparable to standard clinician measurements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/1/2024
8 months - 2
FDA Approval
12/23/2024
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