Regulatory

GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan™ (gadoterate meglumine) Injection for Intravenous Use

Clariscan, approved in more than 55 countries globally with over four million patient doses shipped, is now FDA-approved in the U.S. Expands the GE Healthcare portfolio of contrast media products CHALFONT ST GILES, England–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) […]

ANI Announces Plans to Launch Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml) for Ventricular Arrhythmias

BAUDETTE, Minn., Oct. 31, 2019 /PRNewswire/ — ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced that its partner Pharmaceutics International Inc. (Pii) has received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml).  ANI plans to launch this currently unavailable drug in December, introducing […]

Impulse Dynamics Announces U.S. FDA Supplemental-PMA Approval of its Next Generation Optimizer® Smart System

Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients MOUNT LAUREL, N.J.–(BUSINESS WIRE)–Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering CCM™ (Cardiac Contractility Modulation) therapy, announced today that it has received FDA approval of a PMA […]

The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status

Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies […]

HeartVista Receives FDA 510(k) Clearance for One Click™ Cardiac MRI Package, the First AI-assisted Cardiac MRI Scan Solution

LOS ALTOS, Calif.–(BUSINESS WIRE)–HeartVista, a pioneer in AI-assisted MRI solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration to deliver its AI-assisted One Click™ MRI acquisition software for cardiac exams. Despite the many advantages […]

CORRECTING and REPLACING CAPTION FDA Post Approval Study Demonstrates Timely Identification of Right Heart Failure and Early Use of Impella RP Leads to Higher Survival

CORRECTION…by Abiomed October 26, 2019 09:15 AM Eastern Daylight Time DETROIT–(BUSINESS WIRE)–Please replace the caption for release dated October 25, 2019 with the accompanying corrected caption. The release reads: FDA POST APPROVAL STUDY DEMONSTRATES TIMELY IDENTIFICATION OF RIGHT HEART FAILURE […]

FDA grants “Breakthrough Device Designation” to CorFlow Therapeutics to expedite clinical development and regulatory review of its CoFI™ (COF-fee) System

BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the FDA has designated the company’s CoFI (CorFlow Controlled Flow Infusion) System as a “Breakthrough Device” with a broad indication-for-use statement: “The CoFI™ System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI […]