XCath announced today that the US Food and Drug Administration (FDA) has accepted the company’s Iris surgical robotic system into its Total Product Life Cycle Advisory Program (TAP) pilot—a decision that follows the US regulator granting a Breakthrough Device designation for the system in September 2026. The Iris system is intended for remote, robotic-assisted mechanical thrombectomy in patients with acute ischaemic stroke.
XCath states in a press release that TAP enrolment builds directly on last month’s Breakthrough Device designation; where that prior designation provides interactive engagement with US FDA reviewers, TAP adds “a continuous, strategic dialogue during the period in which the most consequential development decisions are made”. The programme also offers XCath input on the reimbursement and adoption considerations that will shape how remote stroke intervention reaches hospitals and patients, the company adds.
These regulatory breakthroughs follow a clinical milestone from March 2026 whereby—during an investigation known as Operation Robo Angel—Vitor Mendes Pereira (University of Toronto, Toronto, Canada) operated the early Iris system from a control station in Santiago, Panama to treat a patient located more than 120 miles away at The Panama Clinic in Panama City, Panama. XCath describes this procedure as “the world’s first remote, telerobotic mechanical thrombectomy in a living patient”.
“Our mission is to reach stroke patients who, today, may not have timely access to potentially lifesaving care,” said Eduardo Fonseca, chief executive officer (CEO) 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 USA.”
The US FDA’s TAP is a voluntary programme—within its Center for Devices and Radiological Health (CDRH)—for breakthrough-designated devices. The programme is designed to help innovative devices of public health importance reach patients sooner by pairing each enrolled device with a dedicated US 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 US FDA feedback and from facilitated engagement with non-FDA stakeholders—including payers, providers, patient organisations, and medical specialty societies.
XCath notes that enrolment 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 US FDA authorisation, adding that the system remains under development.
