FluidAI Medical's Origin™ device has received FDA 510(k) clearance, a pivotal milestone redefining the future of data-driven, post-operative care

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Sep 26, 2025, 14:33 ET

In the news release, Fluid AI Medical Receives FDA 510(k) Clearance for Origin™, a Real-Time Postoperative Bedside Monitoring Device, issued 24-Sep-2025 by Fluid AI Medical over PR Newswire, we are advised by the company that the news release has been updated. The complete, updated release follows:

FluidAI Medical's Origin™ device has received FDA 510(k) clearance, a pivotal milestone redefining the future of data-driven, post-operative care

FluidAI Medical, a Canadian medical technology company that develops Artificial Intelligence solutions integrating novel sensors, medical devices and software, received FDA 510(k) clearance for Origin™, a real-time monitoring device intended for use with patients recovering from surgery post-operatively.

KITCHENER, ON, Sept. 26, 2025 /PRNewswire/ - FluidAI announced that the U.S. Food and Drug Administration has granted 510(k) clearance for Origin™, an inline sensing system that provides real-time, bedside monitoring of surgical effluent for patients in a post-operative setting. Origin™ can either work as a standalone device and is planned to be integrated with FluidAI's Stream Care™ - an AI-assisted Surgical Expert Suite ⁽¹⁾. The device has been designed to seamlessly connect to standard surgical drains and continuously provide care teams with real-time pH data visualization at the bedside.

510K Clearance for Origin™ (CNW Group/Fluid AI Medical)

The CEO of FluidAI, Youssef Helwa, framed the FDA announcement as a landmark milestone and a pivotal first step in advancing the company's mission & expanding access to new markets: "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. Its continuous sensing unlocks a new data layer, one that will enable our predictive models ⁽²⁾, and will pave 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, welcomed the FDA announcement, saying: "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. 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".

Guen O'Hara, Business Development Manager at FluidAI, addressed this announcement: "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. 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 3.5M patients that undergo general and GI surgeries performed in the U.S. annually".

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.

About FluidAI Medical

At its core, FluidAI Medical is dedicated to advancing data-driven care, 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 & 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 post-operative surgical recovery through advanced sensing and artificial intelligence.

As a trusted partner, FluidAI Medical collaborates with leading hospitals, research institutions, and health systems worldwide to deliver scalable, interoperable and customized solutions that align with evolving models of care. Its portfolio includes 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 Inara ™, 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.

Today, FluidAI stands at the forefront of data-driven surgical innovation, leveraging 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. In doing so, FluidAI is helping health systems set a new global standard for personalized, proactive recovery.

(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 USA - 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.