Regulatory

Vivasure Medical Receives CE Mark Approval in Europe for PerQseal Elite Vascular Closure System

First fully absorbable, sutureless closure system designed for large-bore procedures aims to improve procedural efficiency and patient outcomes in structural heart interventions GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced European CE mark approval of the PerQseal® Elite vascular closure system, a […]

CardioVia Announces FDA Clearance for ViaOne, Opening a New Frontier in Minimally Invasive Heart-Surface Treatments

TEL AVIV, Israel, April 8, 2025 /PRNewswire/ — CardioVia, an innovative medical device company specializing in advanced cardiac care solutions, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ViaOne system. This breakthrough device is…

SUPIRA MEDICAL INITIATES U.S. EARLY FEASIBILITY STUDY (EFS) FOR HIGH-RISK PCI

Company expands clinical program beyond 70 patients already treated in South America FIH and Feasibility Studies. FDA acknowledged potential benefits of the Supira System by granting the company a review pathway under the Breakthrough Device Program. Results from EFS will be used to support submission to FDA for Supira’s pivotal […]

FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDE® Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

MOUNTAIN VIEW, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce that the U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval to initiate its ELITE-BTK pivotal trial of its next generation drug eluting bioresorbable scaffold, MAGNITUDE®, for below-the-knee (BTK) PAD.