The machine learning-based device enables to detect certain biomarkers, which may be indicative of SARS-CoV-2 infection
Tiger Tech Solutions has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its machine learning-based Covid-19 non-diagnostic screening device.
The machine learning-based screening device, which is claimed to be the first of its kind, enables to detect certain biomarkers that may indicate some types of conditions such as hypercoagulation.
The Tiger Tech Covid-19 Plus Monitor is designed for trained personnel to avoid the exposure to and spread of SARS-CoV-2, the virus responsible for Covid-19.
According to the FDA, the device has the potential to detect certain biomarkers, which may be indicative of SARS-CoV-2 infection and other hypercoagulable conditions such as sepsis or cancer or hyper-inflammatory states such as severe allergic reactions in asymptomatic individuals over the age of five.
The device is intended for use following a temperature reading, which does not meet criteria for fever in settings where temperature check is being conducted as per the Centers for Disease Control and Prevention (CDC) and local institutional infection prevention and control guidelines.
The FDA’s Center for Devices and Radiological Health director Dr Jeff Shuren said: “The FDA is committed to continuing to support innovative methods to fight the Covid-19 pandemic through new screening tools.”
Featuring embedded light sensors and a small computer processor, the device is an armband that is wrapped around a person’s bare left arm above the elbow during its use.
Over a period of three to five minutes, the sensors will first secure pulsatile signals from blood flow.
The processor extracts some significant features of the pulsatile signals such as pulse rate, upon the measurement is completed.
Later, the signals will be transformed into a probabilistic machine learning model to help predict whether the individual is showing certain signals, such as hypercoagulation in blood.
The Tiger Tech Covid Plus Monitor’s clinical performance has been assessed in hospital and school settings.
The hospital study, which recruited 467 asymptomatic individuals, shown that the device had a positive percent agreement of 98.6% and a negative percent agreement of 94.5%.