XCath Robotics’ Iris System Accepted into FDA’s Total Product Life Cycle Advisory Program (TAP) for Remote Robotic-Assisted Mechanical Thrombectomy in Acute Ischemic Stroke
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 company announced today. The system is intended for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke. XCath is a medical device company advancing endovascular surgical robotics, and the FDA’s decision comes after it granted Breakthrough Device Designation to the Iris System on September 2, 2026.
XCath Robotics Receives FDA Breakthrough Device Designation for the Iris System for Remote Robotic-Assisted Mechanical Thrombectomy in Acute Ischemic Stroke
XCath Robotics, a medical device company advancing endovascular surgical robotics, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Iris Surgical Robotic System for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke.
