Approval brings U.S. vascular surgeons the first on-label bridging stent graft for both fenestrated and branched endovascular aortic repair, as three-year clinical outcomes demonstrate safety and effectiveness. FLAGSTAFF, Ariz., Oct. 14, 2026 /PRNewswire/ — W. L. Gore & Associates’…
Regulatory
Vantis Vascular Receives FDA Clearance for 6F CrossFAST Model
New 6 French model accommodates a broader range of devices while maintaining the integrated design and deliverability of CrossFAST SAN JOSE, Calif., Oct. 13, 2026 /PRNewswire/ — Vantis Vascular, a medical technology company developing innovative devices for vascular interventions, today…
E2 Secures Dual FDA Clearances for the Hēlo® Platform, Introducing a PE Thrombectomy System with Integrated Blood Return
Combination of Hēlo Thrombectomy System and Hēlo Return establish the first 510(k)-cleared platform compatible with continuous vacuum aspiration MENLO PARK, Calif., Oct. 12, 2026 /PRNewswire/ — Endovascular Engineering, Inc. (E2), a commercial-stage medical technology company focused on…
Enrollment Completed in BIOMAG™-LL Clinical Study Evaluating Longer Lengths for Freesolve™ Resorbable Magnesium Scaffold
WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the successful completion of patient enrollment in the BIOMAG™-LL Clinical Study, evaluating the safety and clinical performance of the Freesolve™ Resorbable Magnesium Scaffold (RMS) in 35 mm and 40 mm lengths for the treatment of de novo coronary lesions up to 38 mm. The study reflects Teleflex’s commitment to expanding clinical evidence supporting the use of the F
GORE ANNOUNCES FIRST PATIENT ENROLLMENT IN THE GORE® EXCLUDER® IBE PLUS STENT GRAFT PIVOTAL STUDY
CAUTION: Investigational device. Limited by United States law to investigational use. FLAGSTAFF, Arizona/USA (October 1, 2026)—W. L. Gore & Associates’ medical business (Gore) announced today the first patient enrollment in the IBE Plus Pivotal Study, a clinical trial evaluating the investigational GORE® EXCLUDER® IBE Plus Stent Graft for the treatment […]
Wellysis Secures FDA 510(k) Clearance for AI-Powered ECG Analysis Software, S-Patch CardioAI
Adds FDA-cleared AI analysis to Wellysis’ S-Patch ECG monitoring solution, expanding its capabilities beyond ECG acquisition Enables FDA-cleared AI analysis of S-Patch ECG data to be integrated into third-party ECG platforms and existing clinical workflows Designed to streamline ECG…
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
HOUSTON–(BUSINESS WIRE)–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 Syste
Okami Medical Receives Expanded Indication for the LOBO Vascular Occluder
ALISO VIEJO, Calif., Oct. 7, 2026 /PRNewswire/ — Okami Medical, a medical technology company developing novel vascular embolization solutions, announced today that the U.S. FDA has granted an expanded indication for its LOBO® Vascular Occlusion System. The expanded indication extends the…
Shape Memory Medical Receives ANVISA Market Authorization for IMPEDE Embolization Plug Family in Brazil
SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., the developer of proprietary volume-expanding shape memory polymer solutions for endovascular embolization, today announced that Brazil’s national health surveillance agency, ANVISA (Agência Nacional de Vigilância Sanitária), has granted authorization for the IMPEDE Embolization Plug, the IMPEDE-FX Embolization Plug, and the IMPEDE-FX RapidFill. The approval process was supported by Biomedical, which acts as Shape Memory Medical’s Br
The Cordis SELUTION SLR SUSTANE™ PTA Drug Eluting Balloon achieves highest reported Primary Patency in US IDE Trial
MIAMI LAKES, Fla.–(BUSINESS WIRE)– #Cordis–Cordis, a global leader in interventional cardiovascular and endovascular technologies, today announced that the SELUTION SLR SUSTANE™ PTA Drug-Eluting Balloon (SUSTANE DEB) achieved the highest reported 12-month primary patency in the SELUTION4SFA US pivotal trial at 90.3%. The results were presented during a Late-Breaking Clinical Trial session at VIVA 2026 by Jay Mathews, MD, MS, Director, Cardiac Catheterization Laboratory, PERT & Structural Heart at



