Biovotion registered Everion® with FDA as medical device
This FDA listing of Everion MD as a wearable vital sign monitor with FDA as a class 2 device exempt from 510(k) notification is the first step to
receive market authorisation in the US and towards a full 510(k) clearance we are aiming at later this year.
With the current registration Everion MD can be used and sold as a medical device in the US. Further details can be looked up here.