The Biomedical Advanced Research and Development Authority has teamed with Northwestern University spinout Sonica Health to develop a clinical-grade wearable for detecting and monitoring COVID-19 infections. The partners plan to file with FDA this month for marketing authorization.
BARDA described the device as a Band-Aid-sized wireless patch that sits at the base of the throat and captures data on cough intensity, breathing, heart rate and other clinical measures affected by the coronavirus in a statement published Wednesday.
The Northwestern researchers behind the patch argue the data it captures is more relevant for assessing COVID-19 than the variables tracked by consumer-grade wearables manufactured by companies such as Apple and Fitbit.
The potential for wearables to identify people infected with COVID-19 has attracted the interest of a number of tech companies and research centers. In theory, wearables can detect changes in heart rate, sleep patterns and other variables that indicate an individual may be infected with the virus. By providing that early warning capability, wearable developers hope to help break chains of viral transmission.
Projects involving wrist-worn wearables sold by companies including Fitbit and Garmin are putting that idea to the test. Yet, some researchers are questioning whether such wearable technology can collect the information that is most relevant to COVID-19.
In an editorial published in Science Advances, the Northwestern University researchers who worked on Sonica’s BARDA-partnered patch argue consumer devices “are highly constrained in measurement modalities and accuracy.” They make the case that consumer-grade, wrist-worn wearables monitor heart rate and physical activity, despite the fact that fever, cough and shortness of breath are the main early symptoms of COVID-19.
As a result, the Northwestern researchers believe chest and neck-worn wearables are better equipped to spot and track COVID-19 infections. BARDA began working with the developer of such a device, VitalConnect, in May. That project is providing a chest-worn patch to nursing home patients to monitor for changes in respiratory rate, blood oxygen levels and other variables linked to COVID-19.
The Northwestern researchers referred to the VitalConnect project in their editorial but contend there is room for another device designed for continuous monitoring of respiratory health. That device, called ADAM, sits at the base of the neck, a location the researchers believe is well suited for recording respiratory activity. Data such as breathing effort, cough frequency and intensity, as well as duration, are analyzed alongside cardiac information and temperature readings captured by the device.
Sonica plans to test the device in 500 subjects by the end of the year, building on an early study of 52 COVID-19-positive physicians, nurses, rehabilitation specialists and patients that captured 3,000 hours of data. In parallel, a thoracic surgeon at Northwestern is using the device to monitor the respiratory health of patients after they are discharged from the hospital.
The next step is to seek U.S. marketing authorization for the device and associated algorithms. Sonica plans to make a joint filing with Sibel Health, another Northwestern spinout, later this month with the support of BARDA.