XCath Robotics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its Iris surgical robotic system for remote robotic-assisted mechanical thrombectomy in patients with acute ischaemic stroke.
For XCath, this designation provides increased opportunities to interact with US FDA experts, and receive support during the regulatory development and review process as the company advances the Iris system.
The designation follows XCath’s March 2026 announcement of the “world’s first” remote telerobotic mechanical thrombectomy in a living patient. During a clinical investigation known as Operation Robo Angel, Vitor Mendes Pereira (St Michael’s Hospital, Toronto, Canada) operated the Iris system from a control station in Santiago, Panama to treat a patient more than 120 miles away at the Panama Clinic in Panama City, Panama.
By enabling specialist physicians to operate on patients remotely, the Iris system could open the door to breaking down the geographic barriers to specialist stroke care, XCath claims.
“FDA Breakthrough Device designation is an important milestone for our mission,” said Eduardo Fonseca, chief executive officer (CEO) of XCath. “We look forward to continued collaboration with the FDA as we advance the development and evaluation of the Iris system. The real-world learnings from our investigational cases are helping us shape the system to expand access to lifesaving stroke care for the millions of patients we ultimately hope to serve.”
