Gili Pro BioSensor (also known as “Gili BioSensor System”)

DEN200038

ContinUse Biometrics Ltd. · granted 2021-04-01 · product code QOK · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates.”
Algorithmsoftware algorithm measures heart and respiratory rate based on analysis of reflected light patterns from motion-vibration signals
source quote (p.2)
“Analysis of these patterns through the software application correlate with heart and respiratory rates, as part of vital signs assessment. The sponsor provided details on how the software algorithm measures heart and respiratory rate.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.4)
“Appropriate documentation was provided in accordance with FDA's 2014 guidance document titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.”

Validation studies (2)

Bench

sample size not stated

endpoints: verify device performance across the intended range of heart and respiratory rates

standards: IEC 60601-1:2005+ CORR. 1:2006 + CORR. 2:2007 + A1:2012, IEC 60601-1-2:2014, IEC 60825-1

Retrospective clinical

n=130 patients

endpoints: accuracy of heart rate for non-arrhythmia subjects; accuracy of respiratory rate for general population; equivalence of the Gili BioSensor System to reference device on heart rate for general population

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN200038