What happened
ContinUse Biometrics of Tel Aviv, Israel, makes the Gili Pro BioSensor. It shines a low-power infrared laser at a seated patient's chest and analyzes the reflected light for the motion of heartbeat and breathing. The sponsor's study enrolled 120 adults aged 29 to 93, with and without arrhythmias. Their readings were compared with ECG and with capnography scored by clinicians. FDA reviewers report that heart rate in patients without arrhythmia met an acceptance limit of ±3 bpm. Breathing rate in all patients met a limit of ±2 breaths per minute. Heart rate in the wider group, arrhythmias included, met a limit of ±5 bpm. No adverse events were reported. FDA granted the De Novo request on 1 April 2021. The reviewers write that readings taken without personal contact can reduce the exposure of staff to infectious agents. The study measured accuracy only and did not measure exposure or infection.
Sources
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Regulatory document, by authors with no tie to the system.
U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo Classification Request for Gili Pro BioSensor (Gili BioSensor System) (DEN200038): decision summary. Granted 2021-04-01.
The device can provide benefit as heart rate and respiratory rate values are obtained without personal contact with a healthcare worker.
Details
AI system
- Workflow
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The patient sat upright in a chair or bed, wearing smooth clothing that was snug against the chest. The sensor aimed an eye-safe infrared laser at the chest and recorded the reflected pattern.
Follow-up
- Conditions for replication
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Healthcare professionals take spot measurements in adults who do not need continuous monitoring. The readings are not used to detect arrhythmias or to monitor apnea.
Entry details
- Sector
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Healthcare.
- Purpose
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ContinUse Biometrics built the Gili Pro BioSensor to take spot measurements of heart and breathing rates without touching the patient.
Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.
Cite this record
Peter H. Vartanian. (2026). Gili Pro BioSensor measured heart and breathing rates without contact (AIBD-0782). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0782.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)