FAQ's

Blinkcns' ML/AI technological platform and EyeStat5 employ a rapid and quantitative method for utilizing a person's eye blink and blink reflex to assess for abnormalities associated with neurological disease and conditions like TBI and Parkinson's disease.

The EyeStat5 device uses mobile phone technology. Blink reflex scan test data is collected over a 30-second testing period. After mounting an iPhone or Android mobile device into the EyeStat5 head-mounted unit, the user accesses the patient's Health Insurance Portability and Accountability Act (HIPAA) compliant medical records, selects the scan type, and initiates the test. During the testing period, the blink reflex is induced eight times using a slight puff of air directed randomly to the corners of the right or left eye. The mobile phone's camera records over 7,000 pictures of the eyes during the test.

Data is sent to the blinkcns AWS cloud, where the analysis is performed using blinkcns' patented ML/AI-based software and generates data profiles of separate and distinct, 100% objective, and measurable parameters of the eye blink. The analyzed data is then used to assess the patient by evaluating their event and concussion status against their baseline analytics and matching "cohort" data for age, sex, and race. The patient's results are displayed in a HIPAA-compliant portal for clinician review.

EyeStat5 and the iPhone/Android app suit both clinicians and patients. The technology enables low-cost, portable, and objective capturing and assessment of a patient's spontaneous, as well as stimulated, blinking in a clinical or at-home setting. It is non-invasive and does not create a cognitive load on a patient. It uses high-speed videography and activation of the blink reflex via an air puff versus an electrical stimulation and has been found to be comparable to the gold standard (i.e., 3D kinematics and EMG).

Under Institutional Review Board (IRB) approved research conducted in 13 colleges and universities, 10 high schools, 4 professional teams, and 3 large hospital systems, blinkcns has collected video scan data on more than 7,000 normative users and 5,405 male and female athletes (including over 150 diagnosed concussions), recording over 39,000 scans and 2,000,000 data points using the EyeStat3 device.

It is being submitted to the FDA for clearance as a Class II Medical Device, using EyeStat3 as the predicate technology. The cleared indication will be to measure and access the blink reflex in a clinic and at-home testing setting.

No, not yet.

If you are interested in a trial period to further evaluate the EyeStat5 technology, please contact us directly.

EyeStat is contraindicated in patients who have a documented history of seizures. EyeStat testing should not be administered on patients who present with an existing eye problem, such as an infection until the problem has been resolved and the patient is approved for testing by a physician or medical professional. EyeStat should not be used in patient populations diagnosed with closed-angle glaucoma patients.