FDA grants EUA to COVID-19 screening device using machine learning

The FDA has granted emergency approval to a machine learning system that identifies signs of COVID-19 infection in asymptomatic or asymptomatic individuals.

The product, which is not classified as a diagnostic device, consists of a tape that uses light sensors and machine learning to detect if a person shows signs of COVID-19, such as B. Hyper-coagulation. The FDA has removed the product for use in people without fever or other symptoms of COVID-19.

Tiger Tech Solutions assured the United States regarding health data from studies in schools and hospitals that most of the time they had correctly predicted the status of COVID-19.

Estimates of the percentage of COVID-19 cases caused by asymptomatic individuals vary, but they make up a significant minority of transmission events even at the lower end of the range. The role of asymptomatic individuals in coronavirus transmission has led to increased efforts to identify hidden carriers of the virus, such as screening programs that use antigen testing.

Tiger Tech has added another product to its portfolio of selection tools. The device is designed for use on anyone with a temperature below 100.4 ° F, which indicates that there are no signs of a fever or other symptoms of COVID-19.

The test person wears the device around their arm for 3-5 minutes. At the end of this time, the device will display a light in one of three colors to indicate whether it has detected biomarkers for conditions such as hyper-coagulation or has a negative or inconclusive result.

Tiger Tech biomarkers are signs that a person has COVID-19, which is affecting blood clotting. If the result is positive, the person should be treated as if they have a high fever. This may mean that the person enters the screening site and needs to be tested for COVID-19 and quarantined until the result.

The FDA approved the United States based on the results of two studies. The product used in hospitals found 69 positive cases in 467 asymptomatic people. A positive agreement rate, also known as sensitivity, was 98.6% and a negative agreement rate was 94.5%. Tiger Tech saw similar results in the school’s confirmation study.

The product provides institutions with another way to determine if someone may be infected with the coronavirus before allowing them to do so. However, by expanding antigen testing to places where people, especially schools, need to be screened and getting results in about 15 minutes, Tiger Tech competes for the asymptomatic screening market.