The Norwegian Medtech company secures U.S. regulatory approval for non-invasive fluid management device
OSLO, Norway–(BUSINESS WIRE)–Mode Sensors (www.modesensors.com) announced today that its Re:Balans hydration monitoring system has received 510(k) clearance from the U.S. Food and Drug Administration, positioning the company to enter the American market with its wearable sensor technology.
The clearance allows Re:Balans to be marketed in the United States 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 device leverages 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 notoriously inaccurate.
There are more than 200 million surgical operations taking place worldwide, and more than 20% of patients experience post-operative complications such as sepsis, acute kidney injury and cardiovascular events leading to higher mortality, higher costs and permanent long-term healthcare needs.
Several of the world’s leading experts within surgical care state that a solution to this problem would be as transformative as the invention of the pulse oximeter and that the market opportunities would be close to endless for the company that solves it.
“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” – states Gøran van den Burgt, CEO and co-founder of Mode Sensors.
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 Q1 2026.
About Mode Sensors
Mode Sensors is a Norwegian medical technology company based in Trondheim developing wearable sensor solutions for fluid management monitoring.
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