Peripheral/Endo

XCath Robotics Receives FDA Breakthrough Device Designation for the Iris System for Remote Robotic-Assisted Mechanical Thrombectomy in Acute Ischemic Stroke

HOUSTON–(BUSINESS WIRE)–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 f

Innova Vascular Completes Enrollment in Trust IDE Study Evaluating the Laguna Thrombectomy System for Pulmonary Embolism

IRVINE, CA, UNITED STATES, August 31, 2026 /EINPresswire.com/ — Innova Vascular, Inc., a medical technology company developing innovative endovascular solutions for the treatment of vascular thromboembolism, today announced the completion of patient enrollment in the TRUST pivotal Investigational Device Exemption (IDE) clinical study evaluating the safety and effectiveness of the Laguna® Thrombectomy […]

Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter

New device expands Vesalio’s pVasc platform with integrated clot-capture technology designed to retain clot fragments during retrieval. DALLAS, Aug. 13, 2026 /PRNewswire/ — Vesalio, a global leader in vascular intervention, today announced that the U.S. Food and Drug Administration (FDA)…

FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System

The U.S. pivotal study will evaluate FastWave’s electric IVL system in patients with peripheral artery disease. MINNEAPOLIS, Aug. 11, 2026 /PRNewswire/ — FastWave Medical, which is developing next-generation intravascular lithotripsy (IVL) technology, has received FDA approval of its Investigational Device Exemption (IDE) application, which clears the company to begin a U.S. pivotal trial of its ArteroTM electric IVL […]

FDA APPROVES LABELING UPDATE REFLECTING EVIDENCE IN RUPTURED AAA FOR GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

FLAGSTAFF, Arizona (July 7, 2026)—W. L. Gore & Associates’ medical business (“Gore”) announced today that the U.S. Food and Drug Administration has approved updated labeling for the GORE® EXCLUDER® AAA Endoprosthesis and the GORE® EXCLUDER® Conformable AAA Endoprosthesis, adding real‑world clinical evidence that supports the use of EVAR devices in appropriately selected patients with ruptured abdominal aortic […]