Mode Sensors said its Re:Balans hydration monitoring system has received 510(k) clearance from the FDA.
The clearance allows Re:Balans to be marketed in the U.S. for non-invasive monitoring of adult patients with fluid management-related health conditions, including those with fluid overload such as end-stage renal disease and patients at risk of dehydration. The company said the device uses proprietary thoracic bioimpedance technology to deliver continuous, real-time fluid status monitoring to assist physicians in fluid management assessment.
Fluid imbalance, such as dehydration and overhydration, affects hundreds of millions of patients annually and leads to complications, prolonged hospital stays, readmissions, and reduced quality of life. Current methods rely primarily on manual fluid charts, physical examinations, and blood tests—an approach that is both labor-intensive and known to be inaccurate.
“We´ve been experiencing a major uplift in interest from large strategics that are slowly discovering that fluid management is a huge untapped market opportunity potentially worth billions of dollars a year. Our solution enables these market opportunities in completely new ways," said Mode Sensors CEO Gøran van den Burgt.
The company is currently raising series A funding to launch Re:Balans in the surgical ward and already have strong clinical partnerships in place. The company also have multiple industrial collaboration discussions and partnerships ongoing within a wide field of applications such as defense, gastrointestinal, surgical- and elderly care.
Mode Sensors expects EU medical device clearance in the first quarter of 2026.
