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

The Gili Pro BioSensor offers a contactless method for monitoring heart rate and respiratory rate by using near-infrared light to sense chest wall vibrations. Clinical trials have validated its accuracy as comparable to traditional devices, establishing it as a hygienic and non-invasive alternative for spot-check vital sign assessments.

The Gili Pro BioSensor is an innovative contactless device engineered for monitoring critical vital signs, specifically heart rate and respiratory rate. Its core methodology involves emitting near-infrared light towards a patient, who can be either seated or lying down, and then detecting the subtle vibrations of the chest wall induced by cardiopulmonary activity; these measurements are subsequently displayed on a monitor for convenient spot-check assessments by healthcare professionals without requiring any physical patient contact. Clinical validation studies have affirmed the Gili Pro BioSensor's efficacy and accuracy, demonstrating performance comparable to established traditional methods like finger-clip pulse oximeters and chest-strap monitors. Notably, the device maintained its reliability even when used with subjects presenting challenging physiological conditions, such as arrhythmias or high Body Mass Indexes (BMI), consistently staying within acceptable margins of error, positioning it as a hygienic and non-invasive alternative for vital signs monitoring.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the Gili Pro BioSensor differentiate between chest wall vibrations caused by cardiac activity versus respiratory activity or other patient movements?; What is the optimal operational distance and angular range for the Gili Pro BioSensor, and how is its accuracy affected by variations in patient positioning or clothing?; Were specific types of arrhythmias evaluated in the clinical trials, and did the device's accuracy vary among them?; What are the 'acceptable error margins' mentioned in comparison to traditional devices, and how were these determined?; Are there plans to expand the Gili Pro BioSensor's capabilities beyond spot-check assessments to include continuous monitoring or data logging?