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

by ContinUse Biometrics  · Based in Israel → — SENSING MADE SIMPLE.
Cardiology Critical Care Pulmonology

Contact for pricing
Regulatory Status Disclosed

Overview

ContinUse Biometrics, also known as Donisi Health, develops a unique optical sensing unit and data platform that captures medical-grade physiological information remotely, without any physical contact. The core technology, exemplified by the Gili Pro BioSensor (also known as “Gili BioSensor System”), utilizes patented methods for nano-level detection and analysis of vibrations associated with the movement of internal organs and molecules. The system employs an optical sensor and advanced AI algorithms to obtain and analyze video signals, estimating biomedical parameters such as heart rate and respiratory rate. This data is streamed to a health cloud, providing unique and actionable insights to end-users. The device is designed for use by or under the supervision of healthcare professionals for adult patients in various medical care settings, including hospitals and outpatient clinics, as well as for clinical research purposes. It functions as a spot-measurement tool and is not intended for continuous vital signs monitoring or as an apnea monitor.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Contactless biometric sensing
  • Measures heart rate
  • Measures respiratory rate
  • Optical sensor system with software algorithms
  • AI-powered data analysis
  • Provides actionable physiological insights
  • Remote monitoring capabilities
  • Non-invasive measurement
  • Spot-measurement tool (not continuous monitoring)
  • Designed for healthcare professional supervision

Use Cases

  • Health monitoring in homecare and elderly care
  • Telemedicine applications
  • General clinical care
  • Disease tracking and management
  • Clinical research
  • Use in hospital and outpatient settings

What Physicians Need to Know

Heart Failure Risk Prediction (Pulmonary Congestion Detection)
The Gili BioSensor System is an FDA-cleared, contact-free optical system capable of detecting early signs of lung congestion, a critical factor in preventing heart failure hospitalizations. It utilizes machine learning algorithms to analyze chest motion vibration data for this purpose. Studies have demonstrated a sensitivity and specificity of 0.91 for detecting lung congestion, with an overall accuracy of 91%.
Contact-Free Monitoring
The device offers non-invasive, contact-free monitoring by capturing motion-vibration signals from an illuminated surface, eliminating the need for wires, patches, or wearables.
Heart Rate and Respiratory Rate Measurement
The Gili Pro BioSensor is FDA-cleared for the spot measurement of heart rate and respiratory rate in adult patients. Clinical studies have shown over 99% accuracy in detecting heart and respiratory rates.
AI-Powered Analysis
The system employs proprietary AI-based algorithms to detect and analyze multiple health bio-indicators simultaneously, delivering clinically meaningful insights.
Real-Time Alert Capability
The Gili system provides clinically meaningful insights and notifications of changes in key health indicators, enabling a pre-emptive approach to cardiac and pulmonary health monitoring.
Physician Tip

The Gili Pro BioSensor is a valuable tool for non-invasive, contact-free spot measurement of heart rate, respiratory rate, and particularly for the early detection of pulmonary congestion in patients at risk for heart failure exacerbation. Its high accuracy in detecting lung congestion can aid in proactive management and potentially reduce rehospitalizations. However, it is crucial to remember that the system is not intended for continuous vital signs monitoring, nor is it designed to detect arrhythmias or independently direct therapy. Physician oversight and interpretation of the data, in conjunction with other clinical information, remain essential.

The Gili BioSensor System, with its AI-based analysis and ability to deliver clinically meaningful insights and notifications, is designed to support remote patient monitoring. While specific integration partners are not detailed, its focus on providing actionable data suggests potential for integration with telemedicine platforms, electronic health records (EHRs), and other digital health management systems to streamline patient data flow and enhance care coordination for chronic cardiopulmonary conditions.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based (data analysis), Device (sensing unit and mobile unit)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Gili Pro BioSensor (also known as "Gili BioSensor System") received FDA De Novo classification (DEN200038) on April 1, 2021, as a Class II prescription device. It is cleared for optical camera-based measurement of heart rate and respiratory rate in adult patients in a hospital, outpatient, or other medical care settings, or for clinical research purposes.

Integrations
EHR Not specified
Specialties Cardiology, Critical Care, Pulmonology

What the Web Says

The Gili Pro BioSensor, also known as the Gili BioSensor System, is an FDA-cleared, contact-free optical system developed by ContinUse Biometrics. It is designed to remotely capture medical-grade physiological information, such as heart rate and respiratory rate, and can also detect pulmonary congestion. The system utilizes advanced AI techniques for data analysis and is intended for use by healthcare professionals in various medical settings.

Overall: Positive

Strengths

  • Contact-free and non-invasive, improving patient comfort and usability.
  • FDA-cleared for measuring heart rate and respiratory rate.
  • Demonstrated high accuracy (91% sensitivity and specificity) in detecting pulmonary congestion in clinical studies.
  • Can capture physiological data through clothing and with different body mass indexes and skin pigmentations.
  • Potential for use in telemedicine and for early detection of conditions like lung congestion to prevent hospitalizations.
  • Integrates advanced AI and machine learning for data analysis and actionable insights.

Limitations

  • Primarily indicated for use by or under the supervision of healthcare professionals, not untrained lay users.
  • Not intended for continuous vital signs monitoring or as an apnea monitor.
  • Requires the subject to be seated upright and wearing snug-fitting or flattened clothing for measurements.
  • The current required measurement time for detecting lung congestion can be relatively long, though expected to improve.
  • Not intended to independently direct therapy or detect the presence/absence of arrhythmias.
  • Limited public reviews from individual tech reviewers, Reddit, G2, or Capterra specifically for the Gili Pro BioSensor, with some Reddit discussions found for other biosensors (Lingo, Dexcom Stelo) indicating mixed experiences with accuracy and adhesion for those devices.

Based on reviews from: Goodfirms, MyHealthyApple, A Contact-Free Optical Device for the Detection of Pulmonary Congestionu2014A Pilot Study, accessdata.fda.gov, BioSpace, Fintastico, Reddit, CNET

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

FDAnews.com
Donisi Health Gets FDA's De Novo Clearance for Its Gili Biosensor System
Donisi Health received FDA De Novo clearance for its Gili Pro BioSensor system, which uses optical sensors and AI to remotely monitor micro-vibrations for pulse, heart, and respiratory rates.
2022-06
OEM News
Study Demonstrates Promise of Pulmonary Congestion Detection Tech
A clinical study demonstrated the efficacy of Donisi Health's Gili Pro BioSensor for contact-free detection of pulmonary congestion in CHF patients with 91% accuracy.
2022-05
PR Newswire
Donisi Health Presents Data at ACC22 Demonstrating Accuracy of a Contact-Free Medical Device that Detects Pulmonary Congestion in CHF Patients at Home
Donisi Health announced clinical study results at ACC22, showing its Gili Pro BioSensor accurately detects pulmonary congestion in CHF patients at home using contact-free technology.
2022-04
Biosensors (MDPI)
A Contact-Free Optical Device for the Detection of Pulmonary Congestionu2014A Pilot Study
This pilot study demonstrated the efficacy of the FDA-cleared Gili BioSensor System, a contact-free optical device, for detecting lung congestion with high sensitivity and specificity.
2022-10
European Heart Journal - Digital Health
A novel contact-free atrial fibrillation monitor: a pilot study
A pilot study evaluated the Gili Pro BioSensor as a novel contact-free atrial fibrillation monitor, demonstrating its potential for accurate detection compared to standard ECG.
2021-12
Journal of Medical Engineering & Technology
Validation of a novel contact-free heart and respiratory rate monitor
This study validated the Gili Pro BioSensor, a new contact-free system, demonstrating over 99% accuracy in detecting heart and respiratory rates.
2021-04
FDA.gov
Device Classification Under Section 513(f)(2)(De Novo)
The FDA granted De Novo classification for the Gili Pro BioSensor (also known as u201cGili BioSensor Systemu201d) on April 1, 2021, classifying it as a Class II device for optical camera-based measurement of pulse, heart, and respiratory rates.
2021-04
Federal Register
Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
This final order from the FDA codifies the classification of the Gili Pro BioSensor into Class II, establishing special controls for its use in measuring pulse, heart, and respiratory rates.
2023-01

Videos

Product demos, reviews, and walkthroughs for Gili Pro BioSensor (also known as “Gili BioSensor System”).

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Frequently Asked Questions

The Gili Pro BioSensor is a contact-free, table-top optical system designed for spot measurements in various medical settings or for clinical research. It is FDA-cleared to remotely detect heart rate and respiratory rate, with ongoing studies and development for its use in identifying pulmonary congestion, particularly in heart failure patients to help prevent rehospitalizations.
The Gili Pro BioSensor is FDA-cleared as a Class II prescription device for the spot measurement of heart rate and respiratory rate. Its AI algorithms are used to analyze motion-vibration signals to derive these physiological parameters. Donisi Health is actively working to expand its clinical scope and plans to submit for additional FDA clearance for at-home identification of pulmonary congestion.
The device is intended for spot measurements and is not designed for continuous vital signs monitoring or as an apnea monitor. Patients must be compliant with the measurement procedure, typically seated upright with smooth, snug-fitting clothing. While studies show high accuracy for pulmonary congestion detection, the performance of AI algorithms can be influenced by data quality and variability, and human factors can impact real-world usage.
While specific details on Gili's data security protocols are not extensively detailed in public information, generally, AI-powered healthcare devices processing sensitive health data must adhere to stringent data privacy regulations like HIPAA. This necessitates robust encryption, secure storage solutions, and transparent data-sharing policies to protect patient information and ensure responsible data management.
The Gili Pro BioSensor differentiates itself as a contact-free optical system, unlike invasive implantable devices or traditional non-invasive tools that rely on vital signs or weight. It is highlighted as the only FDA-cleared contact-free technology for simultaneous detection of cardiac and pulmonary biomarkers via nano-vibration motion detection. This unique approach aims to provide early detection of conditions like pulmonary congestion to prevent rehospitalizations.
Specific pricing for the Gili Pro BioSensor system is not publicly available in the provided search results. However, for any new medical device in a clinical setting, cost structures typically involve device acquisition, potential subscription fees for software/AI services, and consumables. Reimbursement considerations would depend on established CPT codes for remote patient monitoring and specific diagnostic services, which physicians would need to verify with payers.
The Gili BioSensor's algorithms are developed using machine learning techniques and have undergone clinical validation, demonstrating high sensitivity and specificity in studies for detecting pulmonary congestion. Ensuring freedom from bias and maintaining accuracy across diverse populations is crucial for all AI in healthcare, requiring representative training data and ongoing validation to prevent disparities in diagnostic performance.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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