New COVID-19 Device Approved

The US Food and Drug Administration (FDA) has approved a COVID-19 screening device that may be able to identify the virus in people who are not showing symptoms.

The FDA approved the Tiger Tech COVID Plus Monitor through an emergency use authorization (EUA). The device identifies biomarkers that may point to COVID-19 infection, as well as other conditions like cancer, severe allergic reactions and sepsis.

Trained health professionals are to use the device in settings where people's temperatures are being checked to prevent the spread of COVID-19. Following a temperature check that does not give a reading high enough to be a true fever, this device may identify other signs that the person has COVID-19.

“The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “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.”

The Tiger Tech device is an arm band that uses light sensors to measure factors like blood flow and pulse. After a three- to five-minute reading, the device sends the data to a machine learning computer that predicts the likelihood that the person is showing hypercoagulation (a blood clotting condition that has been tied to COVID-19).

In trials, the device correctly identified COVID-positive people 98.6 percent of the time, according to the FDA. It identified COVID-negative individuals correctly 94.5 percent of the time.

The FDA noted that the Tiger Tech COVID Plus Monitor cannot provide a COVID-19 diagnosis or rule out infection. If you think you might have been exposed to COVID-19 or are experiencing symptoms, reach out to your health care provider.

The FDA granted the EUA for this device to Tiger Tech Solutions, Inc.