KITCHENER, ON, Sept. 24, 2025 /PRNewswire/ - Fluid AI Medical, a Canadian medical technology company, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for Origin™, an inline bio-sensing system that provides real-time, bedside monitoring of surgical effluent for patients in the post-operative setting. Origin™ system can either work as a standalone system or integrated in Stream™ Care - AI assisted Surgical Expert Suite. (1)

Origin™ system is designed to seamlessly connect to standard surgical drains and continuously provide care teams with a real time pH data visualization at the bedside.

The CEO of Fluid AI Medical, Youssef Helwa, framed the FDA announcement as a pivotal step in advancing the company's mission & expanding access to new markets: "This clearance marks a foundational step toward a future of data-driven, post-operative recovery. By transforming what was once an intermittent measurement into a continuous, real-time signal, Origin™ will allow clinicians to see subtle biochemical shifts that may herald optimal recovery or foreshadow complications in the near future. While Origin™ is not yet intended to diagnose post-operative complications in the United States, its continuous sensing unlocks a new data layer— one that fuels Fluid AI Medical's predictive models (2) and paves the way for a new era of intelligent recovery, where patient care becomes proactive rather than reactive" - said Helwa.

Ricky Tjandra, Director for Research and Development at Fluid AI Medical, welcomed the FDA announcement: "I see this clearance as the cornerstone of a larger vision: a world where every drop of surgical effluent becomes an actionable datapoint fuelling the next generation of machine learning algorithms. By unlocking this hidden data layer, we are not simply creating a device — we are igniting a transformation toward intelligent, personalized recovery that will reduce re-admissions and, ultimately, save lives"

Guenevere O'Hara, Global Business Development Manager at Fluid AI medical added: "Transforming a 'dark space' into a transparent, data-rich environment has been the common thread in nearly every major medical breakthrough of the past 50 years. If we reframe intraperitoneal fluid and surgical effluent not as 'waste,' but as a dynamic biochemical mirror of the abdominal cavity, continuous analysis could open entirely new dimensions of proactive, post-operative care across the ~500,000 GI surgeries performed globally each year."

Backed by strategic collaborations with government agencies, leading research consortia, and global healthcare providers, the company is actively expanding the reach of its solutions across North America, Europe, and the Middle East with this clearance.

About Fluid AI Medical

At its core, Fluid AI Medical is dedicated to advancing data-driven care, harnessing real-time information to transform the way patients recover after surgery. Founded in 2014, Fluid AI Medical is a Canadian medical technology company specialized in building digital platforms that turn previously untapped data sources into actionable insights for clinicians, enabling earlier intervention, more precise decision-making, and improved patient outcomes. The company is on a mission to help health systems move from reactive to proactive postoperative recovery through advanced sensing and artificial intelligence.

As a trusted global partner, Fluid AI Medical collaborates with leading hospitals, research institutions, and health systems worldwide to deliver scalable, interoperable and customized digital solutions that align with evolving models of care. Its portfolio includes- but is not limited to- Origin™ (3) , which captures continuous biochemical signals directly from surgical effluent; Stream Care™, an AI-driven Surgical Expert Suite that identifies patients at risk of complications; Stream™ CMx , a Clinical Documentation Generation (CDG) solution using AI to automate documentation processes, enhancing overall operational efficiency by reducing administrative workload and allowing caregivers to dedicate more time to patient care.

Today, Fluid AI Medical stands at the forefront of data-driven surgical innovation—leveraging one of the world's largest clinical datasets to develop intelligent, connected solutions that not only enhance patient safety and operational efficiency, but also deliver measurable economic value to hospitals by reducing complications, shortening length of stay, and increasing overall productivity. In doing so, Fluid AI Medical is helping health systems set a new global standard for personalized, proactive recovery."

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SOURCE Fluid AI Medical