FluidAI has earned U.S. Food and Drug Administration 510(k) clearance for Origin, an inline sensing system that provides real-time, bedside monitoring of surgical effluent for patients recovering from surgery. 

“This is a foundational step toward a future of data-driven, post-operative recovery. Origin will enable clinicians to observe subtle biochemical shifts that may herald optimal recovery or foreshadow complications in the near future,” FluidAI CEO Youssef Helwa said. “Its continuous sensing unlocks a new data layer, one that will enable our predictive models² and will pave the way for a new era of intelligent recovery, where patient care becomes proactive rather than reactive.”

Origin can operate as a standalone device but will be integrated with the company’s Stream Care, an artificial intelligence (AI)-assisted Surgical Expert Suite.¹ The device has been designed to seamlessly connect to standard surgical drains and provide care teams with continuous real-time pH data visualization at the bedside.

“Receiving this clearance marks a significant step forward in surgical care, as it enables the continuous monitoring of surgical drainage to inform the development of smarter, more personalized healthcare algorithms,” FluidAI Director for Research and Development Ricky Tjandra stated. “By tapping into this often-overlooked source of information, we’re not just creating an innovative device, we’re helping enable faster recoveries, fewer re-admissions, and ultimately, saving lives.”

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

“This is a major milestone for all of us. It strengthens our partnerships with U.S. health systems and leading medtech companies while opening doors for exciting new opportunities,” FluidAI Business Development Manager Guen O’Hara commented. “Origin and our portfolio of solutions fit seamlessly within the standard of care, augmenting intraoperative tools to support post-operative management. We look forward to working with hospitals serving the needs of the more than 3.5 million patients that undergo general and GI surgeries performed in the U.S. annually.“

FluidAI Medical advances data-driven care by harnessing real-time information to transform the way patients recover after surgery. Founded in 2014, FluidAI Medical is a Canadian medical technology company specialized in building monitoring and digital platforms that turn previously untapped data sources into actionable insights for clinicians—enabling earlier intervention, more precise decision-making, and improved patient outcomes.

FluidAI Medical collaborates with hospitals, research institutions, and health systems worldwide to deliver scalable, interoperable and customized solutions that align with evolving care models. Its portfolio includes Origin,³ which captures continuous biochemical signals directly from surgical effluent. Stream Care is an AI-driven Surgical Expert Suite that identifies patients at risk of complications, while Stream Inara, is an AI-powered digital companion that engages patients in natural conversations to monitor recovery, address concerns, and deliver personalized guidance while triaging post-operative needs to reduce readmissions and improve outcomes. Stream CMx, a Clinical Documentation Generation (CDG) solution, automates documentation processes, enhancing operational efficiency by reducing administrative workload, increasing profitability, and allowing caregivers to dedicate more time to patient care.

FluidAI leverages one of the world’s largest surgical 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.

References
¹ Stream Care is a Clinical Decision Support System (CDSS) delivered as AI-assisted Surgical Expert Suite to support post-operative care and surgical decision-making.
² Predictive Models: digital software that integrate with clinic EMR. FluidAI’s predictive models are- not available for sale in the USA. Predictive models refers to the process of applying AI and statistical algorithms to historical and current healthcare data to predict future events, enabling hospitals and providers to mitigate complications, optimize resources, and improve patient outcomes.
³ Origin as a part of Stream Platform is not available for sale in the United States. It is an integrated Clinical Decision Support platform and Predictive Analytics ecosystem designed to assist surgeons and care teams throughout the perioperative pathway. It leverages AI-driven insights, real-time data, and surgical expertise to support earlier detection of risks, optimize decision-making, and improve patient outcomes.