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.
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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 stated.
Mechanical thrombectomy is widely regarded as the gold standard treatment for patients suffering a large vessel occlusion (LVO) – the most serious form of ischemic stroke.
XCath highlights, however, that patient access to the procedure on a global basis remains unequal. Research by the World Stroke Organization (WSO) estimates that one in four adults will experience a stroke in their lifetime, yet the global median rate of access to mechanical thrombectomy is just 2.8%.
XCath’s CEO, Eduardo Fonseca, said: “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 life-saving stroke care for the millions of patients we ultimately hope to serve.”
GlobalData analysis reveals that the global robotic surgical systems market is growing at a CAGR of 12.1% and is projected to reach a valuation of around $15bn in 2035, up from around $4.8bn in 2025.
Robotic telesurgery, however, in which a procedure is performed by a surgeon at a remote location, is still in its infancy. Other companies involved in this segment include Sovato and Sentante. Of the pair, Sentante is farthest along in regulatory terms. Following its receipt of FDA breakthrough designation for its remote endovascular robotic surgery platform in September 2025, the Lithuania-based company secured a European CE mark for the platform in May 2026.
