Mode Sensors has gained US Food and Drug Administration (FDA) clearance for Re:Balans, a fluid monitoring wearable, setting the stage for the sensor’s commercialisation in US clinical wards.
With FDA clearance in hand, the Norwegian medical device company currently has a Series A funding round in progress as it sets its sights on the commercial roll-out of the hydration monitoring system.
Re:Blans is a non-invasive wearable sensor indicated for the monitoring of adult patients with fluid management-related health conditions. This includes those with fluid overload such as end-stage renal disease and patients at risk of dehydration.