The Tiger Tech COVID Plus Monitor is an armband with light sensors and a small computer processor for identifying certain biomarkers
The FDA has authorised the use of the Tiger Tech COVID Plus Monitor for detecting Covid-19 in asymptomatic people. (Credit: PIRO4D from Pixabay)
Tiger Tech Solutions has been granted emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Tiger Tech COVID Plus Monitor, a machine learning-based non-diagnostic screening device that can indicate Covid-19 infection.
The screening device can identify certain biomarkers that suggest the presence of some types of conditions like hypercoagulation in the body.
Hypercoagulation, which is commonly seen in Covid-19 patients, is a condition that results in blood clotting more easily than normal.
The Tiger Tech COVID Plus Monitor is an armband that is equipped with light sensors and a small computer processor.
It has to be worn on the bare left arm above the elbow. The device’s sensors first collect pulsatile signals from blood flow in three to five minutes.
After the measurement is completed, the processor extracts certain crucial features of the pulsatile signals. These include pulse rate and others, which are fed into a probabilistic machine learning model.
The model is capable of predicting if the individual is showing hypercoagulation in blood and any other signals.
The result is given via different coloured lights for indicating if a person is showing certain biomarkers, or if the result is not conclusive.
FDA Center for Devices and Radiological Health director Jeff Shuren said: “The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools.
“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, including healthcare facilities, schools, workplaces, theme parks, stadiums and airports.”
According to the FDA, the Tiger Tech COVID Plus Monitor should be used by trained personnel to help avoid exposure to and spread of the SARS-CoV-2 virus.
Apart from Covid-19, the device can identify certain biomarkers that could indicate other hypercoagulable conditions like sepsis or cancer, or hyper-inflammatory states like severe allergic reactions in asymptomatic people, aged over five years.
The Tiger Tech COVID Plus Monitor can be used after a temperature reading that does not match the criteria for fever as set per the Covid-19 protocols.
However, the FDA cautioned that the machine learning-based device is not an alternative for a Covid-19 diagnostic test. Furthermore, it is not indicated to be used in people having Covid-19 symptoms, stated the regulator.