Terumo Interventional Systems Announces Its New OPUSWAVE® Dual Sensor Imaging System and DualView® Imaging Catheter Receive FDA 510(k) Clearance
OPUSWAVE Imaging System combines OFDI and IVUS into a single catheter, providing significant potential to reduce procedural time and costs in treating coronary artery disease DualView imaging catheter offers a 150mm maximum pullback length, a 2.6...
Nuevocor Announces FDA Clearance of IND for NVC-001 for LMNA-Related Dilated Cardiomyopathy
LMNA-related dilated cardiomyopathy (LMNA DCM) is one of the most aggressive forms of DCM, affecting approximately 100,000 individuals in the United States and Europe, who progress rapidly to end-stage heart failure. NVC-001 demonstrated significant...
YolTech Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for YOLT-101, an In Vivo Base Editing Therapy to Treat Heterozygous Familial Hypercholesterolemia (HeFH)
SHANGHAI, June 6, 2025 /PRNewswire/ -- YolTech Therapeutics, a clinical-stage biotechnology company developing in vivo genome editing therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's...
Navi Medical Technologies' Neonav® ECG Tip Location System Receives FDA 510(k) Clearance
Revolutionising Vascular Access Care for Critically Ill Newborns and Children Key Points: FDA 510(k) Clearance Neonav® ECG Tip Location System is now FDA-cleared, enabling its use in U.S. hospitals to enhance pediatric vascular access care....