FluidAI lands FDA clearance to sell post-surgery monitor in the US

FluidAI Medical has received approval from the United States (US) Food and Drug Administration (FDA) to sell its device for predicting post-surgery complications south of the border.

“It took a lot of work [and] a lot of resources for us to come to where we are today.”
Youssef Helwa,
FluidAI

The US FDA granted FluidAI’s Origin product 510(k) clearance as a Class 2 medical device last month, giving the Kitchener-Waterloo healthtech startup key access to the American marketplace.

In an exclusive interview with BetaKit, FluidAI co-founder and CEO Youssef Helwa called this “a major milestone” for the company. He noted that the approval allows FluidAI to bring Origin to patients and hospitals in the world’s largest healthcare market.

“It took a lot of work [and] a lot of resources for us to come to where we are today,” Helwa said. He added that FluidAI has spent the last five years developing and refining Origin and conducting studies and trials across four continents.

Helwa said this approval “opens up the doors” for FluidAI to raise a Series B round to fuel its US expansion, which the startup has already begun working on. He would not share the company’s funding target.

Founded in 2014 and formerly known as Nerv Technology, FluidAI specializes in “data-driven surgical recovery.” The startup develops and sells products designed to predict post-surgical complications by analyzing patient data and fluid. To date, FluidAI has largely focused its efforts on general and gastrointestinal surgery.

FluidAI works with more than 35 medical centres, including Ohio’s Cleveland Clinic and Toronto’s University Health Network. The 85-person company, which closed a $15-million USD Series A round in 2023, has raised just over $20 million in total funding to date. Helwa would not share FluidAI’s current revenue.

Origin is a real-time surgical drain monitor designed to analyze the biochemical composition of patient fluid in order to spot potential complications early. The device attaches to existing drains and uses a combination of sensors and machine learning to measure pH, electrical conductivity, and temperature. The goal is to detect and predict potentially life-threatening anastomotic leaks earlier than symptoms typically manifest.

FluidAI has so far been selling Origin to customers in Canada and the Middle East. Helwa claims he sees “close to” 3.5 million patients in the US alone that Origin could support.

Origin is one of FluidAI’s two core products. The second is its Stream Care software platform. With Stream Care, FluidAI aims to predict the risk of complications following surgery based on patients’ electronic health record information and data gathered from proprietary devices like Origin.

Stream Care uses artificial intelligence (AI) to generate clinical documents, improve coding, and reduce the administrative burden on healthcare professionals. The AI also helps with patient engagement and education, both before and after surgery, through a conversational assistant, wearable integration, symptom flagging, and a central dashboard.

Stream Care is available in hospitals and clinics across Canada, the US, and the Middle East. Helwa said FluidAI already has “more than enough” manufacturing capacity in the Kitchener-Waterloo area to meet the startup’s immediate needs and early US expansion efforts.

Helwa acknowledged that FluidAI has been hurt by US tariffs but claimed that the company has not been hit as hard as other industries. He said FluidAI has worked with partners to minimize the impact. As it gears up to grow in the US, the CEO said the company will establish a US office to support clients, partners, and patients south of the border. Whether it will need to build a manufacturing facility in the US “remains to be seen,” he said.

FluidAI hopes to soon cross a significant milestone by supporting patients across 100,000 total operations. The startup also plans to support a wider variety of surgery types and introduce new products.

Feature image courtesy FluidAI.