Regulatory

First Patients Treated in the US with the World’s Smallest Heart Pump

Magenta Medical initiates its Early Feasibility Study in leading NY cardiology centers KADIMA, Israel, June 7, 2023 /PRNewswire/ — Magenta Medical, developer of the world’s smallest heart pump, announced today the initiation of its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular […]

Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System

IRVINE, Calif, June 7, 2023 /PRNewswire/ — Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever™ System and its Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two […]

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)

This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease   If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways […]