- HHS' Biomedical Advanced Research and Development Authority has provided funding for a validation trial of Empatica's wearable physiological monitor to detect early signs of COVID-19 infection in individuals before the onset of symptoms, potentially encouraging earlier quarantining or treatment.
- The nearly $718,000 BARDA award, announced Friday, will be used to study Empatica's Aura system that uses a smartwatch, sensors and proprietary algorithm. The wearable device measures physiological data such as blood volume pulse, electrodermal activity, heart rate and temperature.
- Wearable devices with health monitoring capabilities are expected to have the strongest performance among smartwatches and fitness trackers as the pandemic and related economic disruption prompts consumers to scale back on non-essential purchases.
The wearables industry sees an opportunity to play a role in reducing the spread of COVID-19 by enabling early monitoring for infection before symptoms present themselves. The CDC estimates 40% of transmissions occur before symptoms are evident.
Empatica is the latest in a growing roster of companies and academic researchers working on COVID-19 detection and monitoring approaches involving wearables. The list includes Fitbit, which is collaborating with the Scripps Research Institute and Stanford Medicine; Finnish startup Oura, working with scientists at the University of California San Diego; as well as Apple and Garmin. Northwestern University researchers have also developed a device that sits on the throat to stream data on coughing and respiratory activity.
BARDA, which has forged a number of partnerships with industry to develop medical countermeasures as part of the government's response to the coronavirus outbreak, said it envisions the Aura system as an "early warning platform" for COVID-19 infections. The system's artificial intelligence-based algorithm calculates the probability of infection.
The BARDA-sponsored study will look to validate the algorithm in real-life settings. Physiological data from healthcare workers wearing Empatica's E4 medical-grade wristband, collected for 30 days, will be compared against daily nasopharyngeal samples and a daily nasal swab. Study participants will collect saturated oxygen readouts for analysis by Empatica and report symptoms, with all the data used to fine-tune the algorithm, the company said.
The BARDA-Empatica partnership intends to pursue an FDA emergency use authorization for the Aura system.
The collaboration is an outgrowth of Empatica's work with BARDA, announced in 2019, focused on developing a digital biomarker to predict serious respiratory infection, and based on the technology of its FDA-cleared smartwatch worn by people with epilepsy as a seizure detection and alert system.
It is not BARDA's first investment in a wearable device intended as an early warning system for COVID-19. The agency also this month teamed with Evidation Health, providing $720,000, to test use of sleep and activity data in creating an algorithm for early detection of the virus. BARDA and Evidation are also working together on research into the use of wearables to monitor influenza.
Manufacturers are forecast to ship 254 million wearables in 2020, up 5% from 2019's volume of 241 million shipments, according to advisory firm ABI Research. The firm had looked for a 17% rise in shipments prior to the pandemic.