XCath Robotics' Iris System Accepted into FDA TAP Program for Robotic Stroke Treatment

According to Surgical Robotics Technology, the U.S. Food and Drug Administration (FDA) has accepted XCath's Iris Surgical Robotic System into its Total Product Life Cycle Advisory Program (TAP) Pilot. The system is intended for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke. The FDA's decision comes after it granted Breakthrough Device Designation to the Iris System on September 2, 2026. TAP is a voluntary program within CDRH for Breakthrough-designated devices, pairing each enrolled device with a dedicated FDA TAP Advisor and providing early, frequent, and strategic engagement across clinical development, regulatory strategy, and market access, with defined timelines for FDA feedback. For XCath, TAP enrollment builds directly on the Breakthrough Device Designation, adding a continuous strategic dialogue and input on reimbursement and adoption considerations. In March 2026, during a clinical investigation known as Operation Robo Angel, Dr. Vitor Mendes Pereira operated the early Iris System remotely from Santiago, Panama, to treat a patient more than 120 miles away in Panama City, the world's first remote telerobotic mechanical thrombectomy in a living patient. Mechanical thrombectomy is the gold standard for large vessel occlusion stroke, but the global median rate of access is just 2.79%. TAP enrollment does not change statutory or regulatory requirements and does not guarantee future marketing authorization. The Iris System remains under development and is not yet cleared for commercial distribution in any country. This information comes from the original source and was organized by AI.