Irvine, CA – July 8, 2026 – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) approved the Dual Energy THERMOCOOL SMARTTOUCH SF Platform (DE STSF), an integrated catheter ablation solution that enables electrophysiologists to deliver both radiofrequency (RF) and pulsed field (PF) energy through […]
Regulatory
VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial
Milestone in pivotal IDE evaluation of VisONE™ Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation Milestone in pivotal IDE evaluation of VisONE™ Synchronized Diaphragmatic Stimulation Therapy for symptomatic heart failure with reduced ejection fraction; FDA Breakthrough Device Designation
Elucid Announces First Patient Enrollment in AI-PREDICT, a Landmark International Study to Define Lesion-Level Cardiovascular Risk
BOSTON–(BUSINESS WIRE)– #Atherosclerosis–Elucid, an innovator in AI-powered coronary CT angiography (CCTA) analysis, today announced first patient enrollment in AI-PREDICT, a retrospective, international, multicenter study designed to establish a new lesion-centric paradigm for cardiovascular risk stratification. Enrollment is underway at three of more than 20 planned sites across the U.S., Europe, and Asia: Emory University, the Medical University of South Carolina, and Centro Cardiologico Monzino, Milan, led
Shape Memory Medical Completes Enrollment in Landmark AAA‑SHAPE Randomized Controlled Pivotal Trial
SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., developer of the only commercially available volume‑expanding shape memory polymer for endovascular embolization, announced today that it has completed enrollment in the AAA‑SHAPE Pivotal Trial, a prospective, multicenter, randomized, open‑label controlled study evaluating the safety and effectiveness of the IMPEDE‑FX RapidFill® Device when used alongside endovascular aneurysm repair, or EVAR, to improve abdominal aortic aneurysm (AA
Nyra Medical Announces First Patient Enrollment in ENHANCE Early Feasibility Study, Advancing Next Generation Mitral Valve Repair Platform
Global clinical program expands to the United States and Brazil following successful First-in-Human experience, marking a major milestone in development of the CARLEN™ System ATLANTA, July 7, 2026 /PRNewswire/ — Nyra Medical, Inc., a clinical-stage medical technology company developing a novel transcatheter solution for functional mitral regurgitation (FMR), today announced enrollment of […]
AtaCor Medical Announces First Patient Treated Globally in its ALARION-EV Pivotal Trial
Study will evaluate AtaCor’s investigational Atala™ lead in conjunction with Abbott’s investigational EV-ICD pulse generator Study will evaluate a novel parasternal extravascular ICD approach for the treatment of life-threatening ventricular tachyarrhythmias SAN CLEMENTE, Calif., July 7,…
Xeltis exceeds 50% enrollment in US Pivotal trial for aXess™, its vascular access device for hemodialysis
Xeltis announces that it has exceeded 50% enrollment in its US pivotal trial for aXess™
Laplace Announces FDA IDE Approval of TRIUMPH Pivotal Trial of Its Transcatheter Tricuspid Valve Replacement System
MINNEAPOLIS, June 29, 2026 /PRNewswire/ — Laplace Interventional today announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for TRIUMPH, the company’s pivotal trial evaluating its Transcatheter Tricuspid Valve Replacement…
PorTal Access Announces FDA Clearance of FLEXI-PORT™ family of implantable vascular access ports
MIAMI, June 22, 2026 /PRNewswire/ — PorTal Access, Inc., an innovative medical device company advancing vascular access technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the FLEXI-PORT™ family of implantable vascular access ports….
GuideAI Health Receives FDA 510(k) Clearance for VascularAssist Occlusion Triage
AI-Powered Triage Software Helps Radiologists Identify and Prioritize Peripheral Vascular Disease in Lower-Extremity CT Imaging AI-Powered Triage Software Helps Radiologists Identify and Prioritize Peripheral Vascular Disease in Lower-Extremity CT Imaging



