Today, the U.S. Food and Drug Administration issued an emergency use permit (EUA) for the first non-diagnostic screening tool for learning-based Coronavirus Disease 2019 (COVID-19) that identifies specific biomarkers that are an indication of certain types of conditions, such as hypercoagulation (a condition that causes a blood clot more easily than usual).
The Tiger Tech Monitor COVID Plus is intended for use by trained staff to help prevent the spread and transmission of SARS-CoV-2, the virus that causes COVID-19. The device identifies specific biomarkers that may be a sign of SARS-CoV-2 infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in the asymptomatic individuals over 5 years. . COVID Plus Tiger Tech Monitor is designed for use after temperature readings that do not meet criteria for fever in situations where temperature monitoring is performed in accordance with the Centers for Disease Control and Prevention (CDC) and guidelines local for infection prevention and control local institution. . This device is not a replacement for the COVID-19 diagnostic test and is not intended for use in individuals with COVID-19 symptoms.
The FDA is committed to supporting innovative methods to fight the COVID-19 pandemic through new screening devices. Combining the use of this new screening device, which may present the presence of specific biomarkers, with temperature analyzes could help identify individuals who may be infected. with the virus, thus helping to reduce the spread of COVID-19 in many public settings, including health care facilities, schools, workplaces, theme parks, stadiums and airports. ”
Jeff Shuren, MD, JD, Director, FDA Radical Health and Equipment Center
The device is armed with embedded light sensors and a small computer processor. The armband is wrapped around a person’s left arm above the burn when in use. The sensors first receive pulsatile signals from a blood stream over a period of three to five minutes. Once the measurement is complete, the processor extracts some key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model trained to pre- tell if the individual is showing certain symptoms, such as hypercoagulation in blood. Hypercoagulation is known to be a common anomaly in COVID-19 patients. The product is presented in the form of light of different colors which is used to indicate whether a person is exposed to certain biomarkers, or whether the result is inconclusive.
The clinical performance of COVID Plus Tiger Tech Monitor was monitored in hospital and school settings. The hospital study, which was considered a confirmatory study, recorded 467 asymptomatic individuals, including 69 confirmed positive cases, and showed that Tiger Tech Monitor COVID Plus had a positive percentage approval (proportion of COVID positive people -19 correctly identified by the device to own specific biomarkers) of 98.6% and negative approval percentage (proportion of the COVID-19 negative persons correctly identified by the device as not owning biomarkers special) of 94.5%. The school inspection, which was regarded as a pilot study, showed similar performance.
Tiger Tech Monitor COVID Plus is not a diagnostic tool and cannot be used to detect or rule out SARS-CoV-2 infection. The device is intended for use on individuals without fever. A person ‘s underlying condition can affect the COVID-19 performance associated with the device and this may result in an incorrect screening result.
The FDA sent the EUA to Tiger Tech Solutions, Inc.
Source:
U.S. Food and Drug Administration