Mode Sensors takes a step towards the US market

The Trondheim-based company Mode Sensors has received clearance from the US Food and Drug Administration (FDA) to market its product in the United States. The approval opens the door to a large international market – and marks an important milestone for Norwegian health technology on its path to global expansion.

The company’s solution, Re:Balans, is designed for continuous monitoring of patients’ fluid balance. The sensor is attached directly to the body and performs measurements in a non-invasive and patient-friendly manner. The goal is to give healthcare professionals better decision support and contribute to more precise and safer follow-up during and after treatment.

“This is the result of a decade of focused work to solve a fundamental challenge in modern healthcare,” says Gøran van den Burgt, co-founder and CEO of Mode Sensors.

The FDA clearance was granted through the 510(k) process, which applies when a new technology is deemed substantially equivalent to an existing product already on the market. This is one of the most efficient pathways to market entry for medical devices in the U.S.

“The U.S. approval covers a broad scope and can be applied to many different patient groups. This opens a significant market potential,” says van den Burgt.

Scaling globally from Norway

With FDA clearance in place, Mode Sensors is now planning a major funding round to scale operations across the Nordics, Europe, and the Americas. The company is also working toward CE marking in Europe.

“The FDA is one of the world’s most rigorous regulatory authorities. Achieving this approval is a major quality stamp and provides a solid foundation for international growth,” says Magnus Nordahl, co-founder and Head of Regulatory Affairs at Mode Sensors.

Part of a growing Norwegian ecosystem

Mode Sensors is a member of Norway Health Tech, which provides access to a strong national and international network within testing, validation, and market introduction. The FDA clearance demonstrates how Norwegian health technology companies can succeed globally through long-term effort, deep expertise, and strategic partnerships.

“This is a fantastic milestone for Mode Sensors – and a strong proof of the international competitiveness of Norwegian health technology,” says Trine Radmann, Head of International Affairs at Norway Health Tech. “Success stories like this inspire the entire ecosystem and highlight the value of collaboration between entrepreneurs, research environments, and international partners.”

The story was first published in MedWatch.