Empatica has received a CE mark for its Aura system, which detects and provides a warning of respiratory infections such as Covid-19 early and before visible symptoms appear.
The CE mark has also been granted to the company’s Care remote health monitoring platform.
Aura’s algorithm assesses vital signs from the company’s smartwatches and compares data against historical baselines, which are unique to each user.
If changes in a wearer’s data indicate that their body is starting to fight an infection, Aura displays a warning to Empatica’s smartphone-based Care App and the Cloud-based Care Portal, optionally alerting their healthcare provider or caregivers.
Healthcare specialists can remotely monitor the risk status of hundreds of people through Care Portal, paving a path for Aura as a potent tool for maintaining healthy communities and in outbreak prevention.
Empatica CEO Matteo Lai said: “Our goal with Aura was to create an effective, scalable, and affordable tool for screening infection risk and supporting testing efficiency, all while monitoring people’s health remotely.
“We hope Aura can play an important role in controlling new outbreaks and helping people safely get back to work and to a normal life.”
Aura demonstrated a sensitivity of 0.94 in identifying patients with a possible infection in validation studies. The results are relevant to general physiological responses that arose from three H1N1, Rhinovirus, and SARS-CoV-2 viruses.
Aura can be used in individuals aged 14 years and older and is now available across Europe and the UK for healthcare providers and other specialists.
Working on obtaining US Food and Drug Administration (FDA) approval for Aura, Empatica collaborated with the US Department of Health and Human Services and Stanford University to carry out a nationwide validation study with US-based healthcare workers.