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.

The FDA’s Breakthrough Devices Program is designed to support the development of medical devices that have the potential to provide more effective treatment for patients with life-threatening or irreversibly debilitating conditions. For 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 designation follows XCath’s landmark March 2026 achievement: the world’s first remote telerobotic mechanical thrombectomy in a living patient. During a clinical investigation known as Operation Robo Angel, renowned neurosurgeon Dr. Vitor Mendes Pereira, 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.

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. Mechanical thrombectomy is widely regarded as the gold standard treatment for patients suffering a large vessel occlusion (LVO) stroke – the deadliest and most disabling type of ischemic stroke. However, access to the procedure remains unequal.

Currently, it is estimated that one in four adults will experience a stroke during their lifetime, yet the global median rate of access to mechanical thrombectomy is just 2.79%. For patients suffering a large vessel occlusion (LVO) stroke, the consequences of missing timely treatment can be devastating, with 77% of patients either dying or being left with severe disability.

“FDA Breakthrough Device Designation is an important milestone for our mission,” said Eduardo Fonseca, Chief Executive Officer of XCath. “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.”

About the Global Stroke Burden

Stroke is the second leading cause of death worldwide and the third leading cause of death and disability combined. Each year, approximately 15 million people suffer a stroke globally. Five million of them die. Another five million are left permanently disabled – unable to speak, to move, to care for themselves or their families. Since 1990, the absolute number of strokes has risen by 70%, driven by population growth, aging, and the widening reach of cardiovascular risk factors.

The cruelest dimension of this crisis is not its scale – it is its inequality. An estimated 87% of all stroke deaths and disability occur in low- and middle-income countries, where access to advanced care is scarce, specialists are few, and the infrastructure to deliver time-critical intervention is often nonexistent. In the United States alone, someone suffers a stroke every 40 seconds.

About XCath Robotics

Founded in 2017, XCath Robotics is a dynamic startup and the industry leader in the mission to improve neurovascular care through robotic capabilities. XCath’s Iris System is the only endovascular robotic system to have achieved remote in human robotic intracranial navigation. With strategically located campuses in Houston, Texas – home to the world’s largest medical center – and Pangyo, South Korea, often referred to as the Silicon Valley of Korea, XCath is committed to bringing its innovative solutions to patients around the world.

The XCath Iris endovascular surgical robotic system is currently under development. It is not yet cleared for commercial distribution in any country.

Public Health Reminder: Stroke is an emergency. Acting quickly can save brain function and lives. Remember FAST – Face drooping, Arm weakness, Speech difficulty. Time to call emergency services immediately.

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