MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization.

Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. Data is collected using custom-made photoplethysmography and electrodermal activity sensors, a high-precision 3D microelectromechanical accelerometer and gyroscope, and a digital thermometer, said Marianne Xenophontos, Empatica’s marketing director. Combinations of this data – including pulse rate, pulse rate variability, interbeat interval and skin temperature and electrodermal activity – can be preanalyzed by algorithms and used as digital biomarkers.

In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.

Boston-based Empatica initially trained the algorithm in 2018 and 2019 on data collected in studies conducted with Columbia and Duke Universities, after receiving HHS funding to develop an influenza-detection wearable. That data focused on H1N1 and rhinovirus patients. Following the COVID-19 outbreak, the company launched COVID-specific studies with Stanford and the University of Miami, as well as the U.K. National Health Service and U.K. army, to collect data on COVID-positive cases to validate the algorithm. The company previously did this with its epilepsy detection algorithm, which was developed and validated in 2018 and U.S. FDA-cleared in 2019.

The study with Stanford, which is being run in partnership with the Biomedical Advanced Research and Development Authority, part of HHS’ Office of the Assistant Secretary for Preparedness and Response, is still actively recruiting, Xenophontos told BioWorld. It is focused on frontline workers and health care workers, the two key groups that could benefit from a solution like Aura.

“Aura has been designed for health care monitoring within communities, where one positive case can lead to an outbreak if not isolated quickly,” she said. The tool is intended for use only by professionals, and not for personal use.

Aura requires no manual input, automatically sending a warning to Empatica’s smartphone-based Care App when a user’s data suggest the onset of an infection. The information also goes to the cloud-based Care Portal, where it can be shared with the person’s health care provider or caregivers.

Importantly, health care professionals can use the portal to simultaneously monitor the infection risk status of hundreds of individuals – providing a potent means of controlling outbreaks and keeping communities safe. Use cases include hospitals that purchase the solution and roll it out to patients with chronic diseases who might be at risk of respiratory infections, or employers who want to prevent outbreaks in the office.

Aura users can lease the wearables and pay for the software solution on a monthly basis. While Aura does not require a prescription in the EU, it will be available only via prescription in the U.S., Xenophontos said.

“Our goal with Aura was to create an effective, scalable and affordable tool for screening infection and risk and supporting testing efficiency, all while monitoring people’s health remotely,” said Matteo Lai, Empatica’s CEO. “We hope that Aura can play an important role in controlling new outbreaks and helping people safely get back to work and to a normal life.”

The company is discussing future U.S. availability with the FDA through two different channels – first, an emergency use authorization to help fight the pandemic, and then a definitive market clearance for the product.

“Based on our regulatory analysis, we envision for Empatica Aura a de novo submission, since there are no cleared devices that are comparable with Aura currently on the market,” Xenophontos said.