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FIZE Medical, a medical technology company focused on precision fluid management for critically ill patients, has received CE Mark and UKCA certification for its FIZE kUO® System, paving the way for commercial operations across Europe and the United Kingdom. The regulatory approvals enable the company to begin product distribution, expanding access to its real-time digital monitoring technology for intensive care teams across the region.
The milestone represents a key step in FIZE Medical’s international growth strategy. With an established commercial presence in North America and Japan, the company is now positioned to expand into two more major healthcare markets, bringing its precision fluid management solution to hospitals throughout Europe and the UK.
“Receiving the CE Mark and UKCA Certification is a pivotal milestone for FIZE Medical,” said Dror Zerem, CEO of FIZE Medical. “It validates the safety, performance, and clinical value of our technology and marks an important step in bringing our solution to hospitals in the EU and the UK. We look forward to partnering with hospitals across Europe and the UK to equip intensive care teams with continuous, real-time digital monitoring that supports precision fluid management, earlier clinical intervention, and better patient outcomes.”
To support its commercial launch, FIZE Medical has established strategic partnerships with leading medical device distributors across key European markets. The company has also localised its platform for its initial launch countries, offering native-language interfaces to help healthcare professionals integrate the system more easily into clinical workflows.
With its commercial infrastructure now in place, FIZE Medical is ready to begin serving hospitals across Europe and the UK, providing clinicians with continuous, automated monitoring to support informed fluid management decisions and timely interventions for critically ill patients.
The regulatory approvals follow another milestone announced earlier this year. In March, FIZE Medical completed a $6 million warrant exercise, bringing its total Series A financing to $36 million. The funding is expected to support the company’s ongoing commercial expansion and continued product development.
FIZE Medical develops technologies that help clinicians optimise fluid management for critically ill patients. Its proprietary FIZE kUO® System delivers continuous, real-time monitoring that supports precision fluid management, enabling earlier clinical intervention and helping improve patient outcomes.
Looking ahead, the company plans to continue advancing its platform through AI-driven data insights, ongoing clinical validation, and expanded global availability as it strengthens its presence in healthcare markets worldwide.
Looking to stay updated on the latest innovations in critical care, digital health, and AI-driven medical technologies? Join industry leaders at MedTech World Asia 2026, taking place from 26–28 August at the Hong Kong Convention and Exhibition Centre. The event will bring together startups, investors, healthcare providers, and global innovators to explore the technologies advancing the next generation of healthcare.
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