Information for US customers

Clearance
Re:Balans is a FDA-cleared wearable sensor system for non-invasive, continuous monitoring of fluid status in adult patients. Developed by Mode Sensors, this medical device leverages proprietary technology to provide real-time fluid management data, enabling healthcare providers to make more informed clinical decisions.
Re:Balans is indicated for non-invasive monitoring of adult patients with fluid management-related health conditions, including patients with fluid overload, such as those with end-stage renal disease, and patients at risk of dehydration.
Fluid imbalance—including dehydration and overhydration—affects hundreds of millions of patients annually, leading to serious complications, prolonged hospital stays, increased readmissions, and reduced quality of life. With more than 200 million surgical operations performed worldwide each year, over 20% of patients experience post-operative complications such as sepsis, acute kidney injury, and cardiovascular events, resulting in higher mortality rates and increased healthcare costs.
Current fluid management methods rely primarily on manual fluid charts, physical examinations, and blood tests—an approach that is labor-intensive and notably inaccurate.
Re:Balans utilizes proprietary thoracic bioimpedance technology to continuously measure fluid status non-invasively. The wearable sensor provides real-time data to assist physicians in fluid management assessment, offering a more precise and objective alternative to traditional monitoring methods.
Key Benefits
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Non-invasive measurements
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Provides real-time data for timely clinical interventions
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Complimentary to subjective physical assessments
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Enhanced patient outcomes: Supports better fluid management decisions to reduce complications
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Workflow efficiency: Supports monitoring processes for healthcare provide.

