Last Friday, the US Food and Drug Administration (FDA) issued an emergency use authorisation (EUA) for the Tiger Tech COVID Plus Monitor. The innovative wearable device utilises a probabilistic machine learning model to provide non-diagnostic screening of certain biomarkers which might indicate that an individual is infected with COVID-19. According to the FDA’s press release, the COVID Plus Monitor “is intended for use by trained personnel to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19.”
Tiger Tech has made a name for themselves developing “wearable sensor systems and researching disease state identification.” The novel COVID Plus Monitor is an armband with embedded sensors that acquire biometric signals, and a small computer processor. It works by identifying biomarkers which might signal the presence of SARS-CoV-2 or other conditions such as cancer, or serious allergic reactions. To use the Tiger Tech COVID Plus Monitor, the device is strapped to a patient’s left arm, above the elbow. Over 3 to 5 minutes, the embedded sensors will monitor the patient’s blood flow to obtain pulsatile signals. After which, the computer processor takes the readings and puts them through its probabilistic machine learning model, where the patient’s biomarkers are compared to thousands of other COVID and non-COVID subjects. Using this statistical analysis, the COVID Plus Monitor determines if the individual is displaying any signals which would indicate biomarkers, such as hypercoagulation, associated with COVID-19. The results of the test are shown through different coloured lights.
The FDA stressed that the Tiger Tech COVID Plus Monitor is not meant to diagnose SARS-CoV-2 infection. Rather, it’s meant to be used on potentially infected persons who have showed no symptoms of COVID-19. In a hospital study, 467 asymptomatic individuals were enrolled, of which 69 were confirmed positive cases. The COVID Plus Monitor successfully identified that 98.6% of the COVID-19 positive individuals possessed specific biomarkers.
As we’ve said, the Tiger Tech COVID Plus Monitor isn’t a standalone solution to diagnose people with SARS-CoV-2 infection. Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health elaborated on this, “Combining use of this new screening device, that can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings”.
This innovative device is part of the US’s commitment to slow the spread of COVID-19, and according to Tiger Tech, is “a game changer that will help stop the spread of COVID-19.”