OSLO, Norway — Mode Sensors announced that its Re:Balans hydration monitoring system has received 510(k) clearance from the U.S. Food and Drug Administration, paving the way for the Norwegian medtech company to enter the American market with its wearable fluid management technology.
The clearance authorizes Re:Balans for use in monitoring adult patients with conditions related to fluid imbalance, including fluid overload in end-stage renal disease and dehydration risk. The system uses proprietary thoracic bioimpedance technology to provide continuous, real-time monitoring of patients’ fluid status, helping physicians assess and manage hydration more accurately.
Fluid imbalance—whether dehydration or overhydration—affects hundreds of millions of people worldwide each year, contributing to complications, longer hospital stays, and higher readmission rates. Current assessment methods rely on manual fluid charts, physical exams, and lab tests, which are often labor-intensive and unreliable.
Globally, more than 200 million surgeries are performed annually, with over 20 percent of patients experiencing post-operative complications such as sepsis, acute kidney injury, and cardiovascular events. Medical experts have described the potential impact of effective fluid monitoring as “transformative,” comparable to the invention of the pulse oximeter, and see vast commercial potential for a successful solution.
“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,” said Gøran van den Burgt, CEO and co-founder of Mode Sensors. “Our solution enables these market opportunities in completely new ways.”
Mode Sensors is currently raising Series A funding to launch Re:Balans in surgical wards and has established several clinical partnerships to support its rollout. The company is also pursuing industrial collaborations across multiple applications, including defense, gastrointestinal health, surgical care, and eldercare.
Mode Sensors expects to receive EU medical device clearance in the first quarter of 2026.
