A pupillometer is a device that measures the Pupillary Light Reflex (PLR)—an involuntary response of the autonomic nervous system to light. Traditionally, pupillometers have been costly and complex clinical tools used in anesthesiology, neurology, and intensive care.
Optovera meets the definition of an automated digital pupillometer, adapted to operational environments because it:
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Uses a smartphone enclosed in a dark visor to create controlled darkness.
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Applies a light stimulus and records the pupillary reaction on video.
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Its algorithms analyze key parameters:
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Initial pupil diameter
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Constriction amplitude
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Latency (reaction onset time)
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Constriction velocity
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Builds a personalized baseline for each worker and compares new tests to that history.
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Is optimized for field use, with immediate results and no need for medical personnel.
FDA Listing and Validation
Optovera is listed with the U.S. Food and Drug Administration (FDA) under device listing number 3017813246 as an “Automatic Pupillometer.”
This means:
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It is registered as a Class II medical device in the FDA database.
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It meets regulatory standards for quality and safety in the U.S.
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While not approved for clinical diagnosis, it is recognized as a valid automated pupillometer for commercial use.
In summary, Optovera is considered a pupillometer, specifically adapted for occupational safety—a fast screening tool for physiological alterations that may pose a risk in critical operations.