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September 14, 2026
XCath’s Iris Robotic System for Stroke Granted FDA Breakthrough Device Designation
KEY TAKEAWAYS
- FDA Breakthrough Device designation is granted for XCath’s Iris surgical robotic system for remote robotic-assisted mechanical thrombectomy in acute ischemic stroke.
- The designation is intended to facilitate interactions with the FDA during development and regulatory review.
- The Iris system remains under development and is not cleared for commercial distribution in any country.
September 14, 2026—XCath Robotics announced that the FDA has granted Breakthrough Device designation to the company’s Iris surgical robotic system for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke.
According to XCath, the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process as the company advances the Iris system.
The company advised that the Iris system is currently under development and is not yet cleared for commercial distribution in any country.
In March 2026, XCath announced the completion of the first telerobotic stroke procedure in a living patient, which was conducted in a clinical investigation known as Operation Robo Angel. Neurosurgeon Vitor Mendes Pereira, MD, 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, noted the company.
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