The Biomedical Advanced Researdh and Development Authority (BARDA) and Boston-based Empatica embark on a new partnership to develop and seek U.S. Food and Drug Administration’s Emergency Use Authorization for Aura, a wearable system and algorithm that can serve as an early warning platform for COVID-19 infections.
This system will utilize a wearable physiological monitor, Empatica’s E4 wristband device, to detect early signs of infection in individuals. Study participants also will self-collect daily nasal swabs, self-report symptoms, and self-collect daily saturated oxygen read-outs for analysis by Empatica. All data will be used to fine-tune and validate Empatica’s early diagnostic algorithm, which will provide a probability of infection.
The results will be shared with the user via a mobile application and a caregiver through a web dashboard. The overall goal of the platform is to provide an early warning to COVID-19 contagion, helping reduce the transmission of infected individuals and save lives.
Individuals infected with SARS-CoV-2 may only seek diagnostic tests once they begin exhibiting symptoms. Empatica aims to disrupt this health-care paradigm by detecting infection in individuals before the onset of symptoms. This project will leverage data from a previous partnership with BARDA on early detection of respiratory infection, and include a clinical study monitoring at-risk healthcare workers for COVID-19. The goal is to alert healthcare workers and patients to infection early, preventing further spread by allowing for early self-quarantine, treatment, and care.
Empatica has prior experience with federal technology transfer. In November, the company introduced the EmbracePlus, a smart watch built in collaboration with the Translational Research Institute for Space Health (TRISH), a partner of the National Aeronautics and Space Administration. TRISH chose Empatica to develop EmbracePlus to be the first wearable to monitor the health of the astronaut crew that will board the first manned mission to Mars.
Read more: https://www.medicalcountermeasures.gov/newsroom/2020/empatica/