PRINCETON, N.J., May 1, 2025 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated…
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…
Brainomix Advances Stroke Care with Landmark FDA Clearance
Brainomix 360 unlocks expert-level insights from universally available non-contrast CT scans, helping stroke networks expand access to life-changing treatments OXFORD, England and CHICAGO, April 8, 2025 /PRNewswire/ — Brainomix, a global leader in AI-powered stroke imaging, has announced…
Q’Apel Medical Announces CE Mark Approval for Armadillo SelectFlex™ Neurovascular Access System
Patented SelectFlex™ Technology allows operators to achieve the ideal balance of trackability and support on demand to navigate complex neurovasculature System enables biaxial approach, regardless of access site, to eliminate complexity and cost of conventional configurations FREMONT,…
Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards
Commercial validation in Europe parallels ongoing RESPONDER-HF clinical trial TEWKSBURY, Mass., Dec. 20, 2024 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, announced today that it has achieved CE certification for the Corvia®…
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 […]
Johnson & Johnson MedTech Receives IDE Approval for OTTAVA™ Robotic Surgical System
Company prepares to support clinical trial in the United States NEW BRUNSWICK, N.J., Nov. 12, 2024 /PRNewswire/ — Johnson & Johnson MedTech, a global leader in cardiovascular, orthopaedic, surgery and vision solutions, today announced that the U.S. Food & Drug Administration (FDA) has…
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.
VANTIS VASCULAR RECEIVES FDA CLEARANCE FOR ITS CROSSFAST™ GUIDE EXTENSION SYSTEM
First and Only Dual Monorail Microcatheter System Purpose-Built for Complex Coronary and Peripheral Interventions SAN JOSE, Calif., Oct. 25, 2024 /PRNewswire/ — Vantis Vascular, Inc., a pioneering medical technology company founded by physicians with a passion to revolutionize vascular…



