FluidAI Medical, a Canadian medical technology company developing AI-driven solutions with novel sensors, has received 510(k) clearance from the US Food and Drug Administration (FDA) for Origin, an inline sensing system that provides real-time, bedside monitoring of surgical effluent in post-operative patients. Origin can operate as a standalone device and is also planned for integration with FluidAI’s Stream Care – an AI-assisted Surgical Expert Suite. The system has been designed to connect seamlessly to standard surgical drains, continuously delivering bedside pH data visualisation for clinical teams.

Youssef Helwa, chief executive officer of FluidAI, described the FDA clearance as a landmark achievement and a pivotal step in advancing the company’s mission and opening access to new markets. “This is a foundational step towards a future of data-driven, post-operative recovery. Origin will enable clinicians to observe subtle biochemical shifts that may indicate either optimal recovery or early signs of complications. Its continuous sensing unlocks a new data layer that will power our predictive models and pave the way for a new era of intelligent recovery, where care becomes proactive rather than reactive,” he said.

Ricky Tjandra, director of research and development, added: “This clearance marks a significant step forward in surgical care, enabling the continuous monitoring of surgical drainage to inform the development of smarter, more personalised healthcare algorithms. By harnessing this often-overlooked source of data, we are not only introducing an innovative device but also helping to support faster recoveries, reduce re-admissions, and ultimately save lives.”

Guen O’Hara, business development manager at FluidAI, highlighted the market impact of the approval: “This is a major milestone for all of us. It strengthens our partnerships with US health systems and leading MedTech companies, while opening new opportunities. Origin and our portfolio of solutions integrate seamlessly with the standard of care, augmenting intraoperative tools to support post-operative management. We look forward to serving the needs of the more than 3.5 million patients undergoing general and gastrointestinal surgeries in the USA annually.”

Supported by strategic collaborations with global healthcare providers, government agencies, and research consortiums, FluidAI is now accelerating expansion across North America, Europe and the Middle East following this clearance.

Founded in 2014, FluidAI Medical develops monitoring and digital platforms that transform previously untapped data into actionable clinical insights, enabling earlier interventions, more precise decision-making and improved patient outcomes.