Business Standard ·
FDA Breakthrough Designation for XCath's Iris System Highlights Potential to Expand Access to Stroke Care in India
New Delhi [India], September 16: XCath Robotics, a medical device company advancing endovascular surgical robotics, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for 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.
"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."