Regulatory

Johnson & Johnson Announces FDA Approval for the Dual Energy THERMOCOOL SMARTTOUCH SF Platform

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 […]

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 […]

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…