US research company Tiger Tech Solutions has designed a wearable sensor that hopes to stop the spread of Covid-19 by improving the ability to identify cases in asymptomatic individuals.
The Covid Plus monitor has recently been authorised for emergency use by the Food and Drug Administration (FDA), the organisation that ensures the safety and efficacy of medical devices and health products in the US.
The armband device is the first machine learning-based Covid screening product to be granted such authorisation. It’s intended for use by trained personnel on individuals over the age of five.
It works by identifying biomarkers – a measurable indicator of a disease state – that could indicate the presence of the virus, such as hypercoagulable conditions (like sepsis or cancer) or hyper-inflammatory states (like allergic reactions).
How it works
The armband contains light sensors and a computer processor. When it’s wrapped around a person’s bare left arm, the sensors track pulse signals from blood flow for a duration of three to five minutes.
Following this, the processor extracts details such as pulse rate from the signals and feeds them into a probalistic machine learning tool, which has been designed to make predictions based on relevant biomarkers like hypercoagulation (a condition that makes blood clots more likely). This has been known as a common abnormality in Covid patients.
The results are indicated through coloured lights; red for positive and green for negative demonstrations of biomarkers. It also indicates whether the results are inconclusive with a blue light. The FDA stresses that the screening tool is not a substitute for a diagnostic test.
The monitor has been tested in hospital and school settings. In the former, over 450 asymptomatic individuals were screens (including 69 confirmed cases) and the monitor had a success rate of 98.6%. That was measured by the proportion of Covid positive people identified correctly by the armband to possess certain biomarkers.
Among its benefits, Tiger Tech lists the armband’s simplicity, speed and security, as it does not require any historical data or cloud storage.
The design process
Tiger Tech chief operations officer Rick Whittington says that all the design and development was done in-house. The product was developed by a team of physicians and engineers at Mount Sinai Medical Center (MSMC) in Miami Beach, Florida.
“It is designed to be simple so Tiger Tech could mass produce the device once approved by the FDA,” he says.
Whittington explains that the research for the product had begun long before 2020, as the company had been taking data sets at MSMC for years. It was in March last year that the team started to identify “’weird’ data”, he adds.
“We knew of Covid-19 in Seattle but had not heard of any reports of it being in Miami, Florida,” Whittington says. But within a week, the entire hospital had been turned into a mass casualty placement centre for Covid patients and all elective operations had been cancelled, he explains.
“Miami had become an epicentre for Covid 19 in the United States,” Whittington adds. After processing data on Covid patients, the Tiger Tech team identified biomarkers of the illness. From there, proprietary algorithms were designed to identify if an individual has these biomarkers.
“We took a fresh look at everything”
Whittington says that there were many challenges in the development of the monitor, but one was how much early information about Covid 19 proved to be false.
“We found ourselves, very early on, ignoring what was coming out about Covid-19 and taking a fresh look at everything,” he says. “The greatest challenge in taking data is finding researchers willing to put on the required PPE, and sit with sick and dying people.”
He believes that the tracker could help “open society as a whole”, firstly by allowing schools to resume regularly again. From there, parents would be able to go back to work.
“We also see this being used in industry such as factories, tourism, airports, and frankly any location where mass gatherings are unavoidable,” Whittington adds.