Fluid AI Medical Receives FDA 510(k) Clearance for Origin™

Fluid AI Medical has 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.

(1) Stream™ Care is a Clinical Decision Support System (CDSS) delivering an AI-assisted Surgical Expert Suite to support post-operative care and surgical decision-making.

(2) Predictive Models: SW that integrates with clinical EMRs. Fluid AI Medical’s predictive models are not for sale in the USA. Predictive models refer to the process of applying AI and statistical algorithms to historical and current healthcare data to predict future events, enabling hospitals and providers to reduce complications, optimize resources, and improve patient outcomes.

(3) Origin™ as a part of Stream™ Platform is not for sale in the USA. Stream™ Platform 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.

Source: Fluid AI Medical