FDA authorizes first machine learning-based screening device for COVID-19 biomarkers

The FDA announced that it authorized the first machine learning-based screening device for identifying COVID-19 biomarkers.

Tiger Tech Solutions’ COVID Plus Monitor received emergency use authorization (EUA) as a non-diagnostic screening device for identifying certain biomarkers that are indicative of some types of conditions, including hypercoagulation (which causes blood to clot more easily than normal), according to an FDA release.

The monitor is intended for use by trained personnel to help prevent exposure to and the spread of SARS-CoV-2, the virus causing COVID-19. The biomarkers it identifies, including other hypercoagulable conditions (like sepsis or cancer) or hyper-inflammatory states, may be indicative of infection with the virus in asymptomatic individuals over the age of five.

Tiger Tech’s monitor is designed for use following a temperature reading that does not meet criteria for fever in settings where temperature check is being…

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