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…
Regulatory
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…
Medtronic receives CE Mark for Evolut™ FX+ TAVI system for treatment of symptomatic severe aortic stenosis
Medtronic plc, a global leader in healthcare technology, today announced it has received CE (Conformité Européenne) Mark for the Evolut™ FX+ transcatheter aortic valve implantation (TAVI) system, the company’s latest Evolut TAVI system for the treatment of symptomatic severe aortic […]
Pi-Cardia Receives FDA Market Clearance for ShortCut™
REHOVOT, Israel–(BUSINESS WIRE)–Pi-Cardia Ltd., a global leader in the development of leaflet modification solutions for treating heart valves, announced today that the United States Food and Drug Administration (FDA) provided market clearance for ShortCut™ – the world’s first dedicated leaflet […]
Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure
– New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring – TOKYO, Sept. 18, 2024 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced…
Piccolo Medical, Inc. Receives FDA Clearance for ECGuide™ Catheter Guidance Technology
SAN FRANCISCO, Sept. 16, 2024 /PRNewswire/ — Piccolo Medical, Inc. (Piccolo) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its innovative catheter guidance technology, the PM2™ System with ECGuide™ Connector. This technology…
Arch Biopartners Announces Alberta Health Services Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI)
TORONTO, Sept. 11, 2024 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that Alberta Health Services (AHS) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
FDA Approves CardiAMP® Heart Failure II Protocol Amendment to Use Proprietary Cell Population Analysis Screening to Define Treatment
BioCardia announced today that the FDA has approved an important protocol amendment for the CardiAMP Heart Failure II Trial, its confirmatory Phase 3 trial
scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX Indication in Heart Failure
FUROSCIX is now indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure, regardless of New York Heart Association (NYHA) functional class