XCath Iris System Gains FDA Breakthrough Device Designation
XCath Robotics has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Iris Surgical Robotic System, which is being developed for remote robotic-assisted mechanical thrombectomy in patients with acute ischaemic stroke.
The designation supports the company’s regulatory development and provides opportunities for increased interaction with FDA experts as the Iris System progresses through evaluation.
The announcement follows XCath’s reported achievement in March 2026 of performing the first remote telerobotic mechanical thrombectomy in a living patient.
During the clinical investigation, known as Operation Robo Angel, neurosurgeon Dr Vitor Mendes Pereira operated the Iris System from a control station in Santiago, Panama, to treat a patient at The Panama Clinic in Panama City, more than 120 miles away.
The Iris System is designed to allow specialist physicians to perform endovascular procedures remotely.
The approach is being developed to help address geographical barriers to access to specialist stroke treatment.
Mechanical thrombectomy is an established treatment for patients with large vessel occlusion (LVO) stroke, but access remains limited in many regions.
Global access to the procedure is estimated at 2.79%.
XCath will continue developing and evaluating the Iris System while working with the FDA on its regulatory pathway.
Breakthrough Device Designation does not constitute FDA approval, clearance or market authorisation.
