FDA Issues EUA on the New AI Device That Can Detect Symptoms Among Asymptomatic Patients
The COVID-19 pandemic has taken a great toll on humanity, but the human race is not backing down. Recently, the United States Food and Drug Administration issued an emergency use authorization to an artificial intelligence device that can scan hidden symptoms of the notorious disease.
Engadget reported that the new technology is one of the medical advances the agency has given their approval. Medical breakthroughs like lab-made monoclonal antibodies, rapid tests that use CRISPR gene-editing technology, Fitbit's Flow ventilator were granted an EUA from the U.S. FDA.
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FDA's EUA on AI Device
FDA described the device to be the first machine learning-based COVID-19 diagnostic screening device. Also known as Tiger tech COVID-19 Plus Monitor, only trained personnel are allowed to use the device to prevent exposure and further spread of SARS-CoV-2.
The AI device uses plethysmography along with a machine algorithm to provide a screening mechanism to mass gatherings, according to a BioWorld report.
UC Health describes the asymptomatic spread of SARS-CoV-2 as the most haunting and mysterious because people who carry the virus that causes COVID-19 have no symptoms or manifestations.
"The FDA is committed to continuing to support innovative methods to fight COVID-19 pandemics through new screening tools," said Jeff Shuren, M.D, the director of the FDA's Center for Devices and Radiological Health. Shuren added that combining the features of the device and temperature checking will help alleviate the spread of COVID-19 in a variety of public places, including schools, health care facilities, and workplaces.
The Emergency Use Authorization issued by the FDA to the AI device allows screening of asymptomatic individuals aging from six years old. The AI device will be used whenever there is a temperature check in mass settings.
The AI device's clinical performance was tested in schools and hospitals. The results of the study between the school and the hospitals showed similar results suggesting that the AI device has shown a positive proportion of COVID-19 positive cases with a rate of 98.6 percent.
How does the AI device work?
In actuality, the FDA-approved AI device is designed to be an armband. The devices also utilize light sensors and a small computer processor that will allow the device to check for biomarkers that can indicate infection from SARS-CoV-2. These biomarkers are hypercoagulable conditions. It can also identify hyperinflammatory states in asymptomatic individuals who may be infected by the virus.
Hypercoagulation is a common COVID-19 abnormality that causes the blood to clot more easily.
The light sensors will either glow green or red. When the light turns green, that means that the patient is not exhibiting symptoms of COVID-19. However, if the light turns red, it means that the device has detected that the patient has symptoms of COVID-19.
Even though the AI device shows great potential in spotting hidden symptoms of COVID-19, the Tiger tech COVID-19 Plus Monitor is not to be used to diagnose COVID-19. The device should solely be used on individuals without fever, and an underlying condition might interfere with the performance of the device.
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