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

Enrollment in the FDA’s selective Total Product Life Cycle Advisory Program follows the Iris System’s Breakthrough Device Designation in September and gives XCath ongoing strategic engagement with the FDA.

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.

The FDA’s Total Product Life Cycle Advisory Program is a voluntary program within the Center for Devices and Radiological Health (CDRH) for Breakthrough-designated devices. The program is designed to help innovative devices of public health importance reach patients sooner by pairing each enrolled device with a dedicated FDA TAP Advisor and providing early, frequent, and strategic engagement with the FDA review team across clinical development, regulatory strategy, and market access. TAP participants benefit from defined timelines for FDA feedback and from facilitated engagement with non-FDA stakeholders, including payers, providers, patient organizations, and medical specialty societies.

For XCath, TAP enrollment builds directly on the Breakthrough Device Designation. Where the designation provides interactive engagement with FDA reviewers, TAP adds a continuous, strategic dialogue during the period in which the most consequential development decisions are made. The program also offers XCath input on the reimbursement and adoption considerations that will shape how remote stroke intervention reaches hospitals and patients.

In March 2026, during a clinical investigation known as Operation Robo Angel, renowned neurosurgeon Dr. Vitor Mendes Pereira operated the early 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 – the world’s first remote telerobotic mechanical thrombectomy in a living patient.

Because the Iris System is designed to enable specialist physicians to operate on patients remotely, it could help remove the geographic barriers that keep people in need from specialist stroke care. Mechanical thrombectomy is considered the gold standard for large vessel occlusion (LVO) strokes, the deadliest and most disabling type of ischemic stroke. However, access to it is far from equal. An estimated one in four adults will experience a stroke during their lifetime, but the global median rate of access to mechanical thrombectomy is just 2.79%. For LVO stroke patients who miss timely treatment, the outcome can be devastating: 77% either die or left with severe disability.

“Our mission is to reach stroke patients who today may not have timely access to potentially lifesaving care,” said Eduardo Fonseca, Chief Executive Officer of XCath. “TAP provides an opportunity for more structured engagement with the FDA and other stakeholders. We believe this engagement can help inform critical development decisions as we pursue our goal of bringing the Iris System to patients in the United States.”

Enrollment in the TAP Pilot does not change the statutory or regulatory requirements that apply to the Iris System and does not guarantee that a future marketing submission will receive FDA authorization. The Iris System remains under development.

About the Global Stroke Burden

Stroke is the world’s second leading cause of death and the third leading cause of death and disability combined. About 15 million people have a stroke every year. Five million of them die, and another five million are left permanently disabled, unable to speak, move or look after themselves or their families. The number of strokes has grown by 70% since 1990, because populations are growing and aging and cardiovascular risk factors are more widespread.

The scale of the problem is not its cruelest feature. The inequality is. An estimated 87% of all stroke deaths occur in low- and middle-income countries, where advanced care is hard to find, specialists are few, and the infrastructure for time critical-treatment is often missing entirely. In just the United States, someone has a stroke every 40 seconds.

About XCath

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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