Mode Sensors Secures FDA 510(k) market clearance for the Re:Balans fluid monitoring wearable
Introduction to Re:Balans
Mode Sensors announced today that its Re:Balans hydration monitoring system has received 510(k) clearance from the U.S. Food and Drug Administration. This clearance positions the company to enter the American market with its innovative wearable sensor technology.
The Re:Balans device will be marketed in the United States for non-invasive monitoring of adult patients with fluid management-related health conditions. This includes patients suffering from fluid overload, such as those with end-stage renal disease, and individuals at risk of dehydration. The device uses proprietary thoracic bioimpedance technology to provide continuous, real-time fluid status monitoring. This assists healthcare providers in assessing fluid management effectively.
The Importance of Fluid Management
Fluid imbalance, whether dehydration or overhydration, affects hundreds of millions of patients each year. These conditions can lead to serious complications, prolonged hospital stays, readmissions, and a reduced quality of life. Current methods for monitoring fluid status primarily rely on manual fluid charts, physical examinations, and blood tests. This approach is labor-intensive and often inaccurate.
The Impact of Surgical Operations
Globally, more than 200 million surgical operations are performed annually. Alarmingly, over 20% of patients experience post-operative complications, including sepsis, acute kidney injury, and cardiovascular events. These complications can lead to higher mortality rates, increased healthcare costs, and long-term healthcare needs.
Several leading experts in surgical care believe that a solution to fluid management issues could be as transformative as the invention of the pulse oximeter. The market opportunities for the company that successfully addresses these challenges are vast.
Market Potential
“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 surgical wards. They have established strong clinical partnerships and are engaged in multiple industrial collaborations across various fields, including defense, gastrointestinal, surgical, and elderly care.
