XCath Robotics’ Iris, a remote robotic-assisted system for performing mechanical thrombectomy in acute ischemic stroke patients, has secured breakthrough device designation from the US Food and Drug Administration (FDA) – paving the way for a streamlined regulatory review.
Designation for the Texas-headquartered company follows Iris’ performance of the world’s first remote telerobotic mechanical thrombectomy procedure in a living patient in March 2026. During the clinical investigation, dubbed Operation Robo Angel, Iris was operated from a control station in Santiago, Panama to treat a patient over 120 miles away at a clinic in Panama City.