The inline sensing system is designed for bedside use with post-operative patients to continuously track biochemical data from surgical effluent.
FluidAI Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Origin device, an inline sensing system that provides real-time, bedside monitoring of surgical effluent for patients in post-operative recovery.
The device is designed to connect to standard surgical drains, where it continuously provides care teams with real-time pH data visualization at the patient’s bedside. According to the company, Origin can function as a standalone device or be integrated with its Stream Care AI-assisted Surgical Expert Suite, a clinical decision support system.
“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,” says Youssef Helwa, CEO of FluidAI, in a release. “Its continuous sensing unlocks a new data layer, one that will enable our predictive models, and will pave the way for a new era of intelligent recovery, where patient care becomes proactive rather than reactive.”
Continuous Monitoring of Surgical Drainage
The goal of the technology is to use a previously untapped data source to help clinicians make more informed decisions. By analyzing surgical drainage fluid, the system aims to support the development of algorithms that can lead to faster recoveries and fewer hospital readmissions.
“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,” says Ricky Tjandra, director for research and development, in a release. “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.”
With this regulatory clearance, the Canadian-based company plans to expand its partnerships with US health systems. FluidAI notes that its solutions are intended for the more than 3.5 million patients who undergo general and gastrointestinal surgeries in the US each year.
“This is a major milestone for all of us. It strengthens our partnerships with US health systems and leading medtech companies while opening doors for exciting new opportunities,” says Guen O’Hara, business development manager at FluidAI, in a release. “Origin and our portfolio of solutions fit seamlessly within the standard of care, augmenting intraoperative tools to support post-operative management.”
Photo caption: Origin
Photo credit: FluidAI Medical
