Regulatory

Foldax, Inc. Gains Approval to Begin US Clinical Trials of the First and Only Biopolymer Heart Valve Platform

SALT LAKE CITY–(BUSINESS WIRE)–Foldax, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval to begin an Early Feasibility Study of the Tria surgical aortic heart valve for the treatment of aortic valve disease. Using breakthrough LifePolymer™ – a proprietary advanced biopolymer material – and […]

Corindus Announces FDA Submission for Neurovascular Intervention Indication for CorPath® GRX Vascular Robotic System

WALTHAM, Mass.–(BUSINESS WIRE)–Corindus Vascular Robotics, Inc. (“Corindus” or the “Company”) (NYSE American: CVRS), a leading developer of precision vascular robotics, announced today it is seeking premarket clearance from the U.S. Food and Drug Administration (FDA) to use the CorPath GRX System in neurovascular intervention. CorPath GRX, the second generation robotic platform, received FDA clearance for percutaneous […]

Medtronic Receives FDA Approval on Expanded Indication for Pipeline Flex Embolization Device

DUBLIN – February 7, 2019 – Medtronic plc (NYSE:MDT) announced today that it has received U.S. Food and Drug Administration (FDA) approval on an expanded indication for its Pipeline(TM) Flex embolization device.1 Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid […]

Teleflex Announces U.S. FDA Premarket Approval of MANTA™ Vascular Closure Device

WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced that it received premarket approval (PMA) from the U.S. Food and Drug Administration for the MANTA™ Vascular Closure Device – the first commercially available biomechanical vascular closure device designed specifically […]

Cook Medical Receives U.S. FDA Approval for Aortic Dissection Device

BLOOMINGTON, Ind.–(BUSINESS WIRE)–Today, Cook Medical announced its recent approval from the U.S. FDA for its Zenith Dissection Endovascular System. The system, consisting of a proximal stent-graft component and a distal bare stent component, provides physicians a less invasive alternative to open surgery for repair of Type B dissections of the […]

Impella Connect Achieves Regulatory Milestone

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) has achieved CE Mark for Impella Connect, the first-of-its kind cloud-based technology that enables secure, real-time, remote viewing of the Impella console for physicians and hospital staff from anywhere with Internet connectivity. European CE Mark adds to Impella Connect’s previous U.S. FDA PMA approval. Impella Connect uses […]

CorMatrix® Cardiovascular, Inc. receives FDA IDE approval to conduct the safety and feasibility clinical trial of the Cor™ TRICUSPID ECM® valve for pediatric and adult patients

ATLANTA, Jan. 24, 2019 /PRNewswire/ — CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cor™ TRICUSPID ECM® cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease. The […]

Rebound Therapeutics Announces FDA Clearance of the Aurora Surgiscope System for Minimally Invasive Neurosurgery

IRVINE, Calif.–(BUSINESS WIRE)–Rebound Therapeutics® Corporation today announced FDA 510k clearance of their AURORA Surgiscope® System, the world’s first single-use disposable Neurosurgical Endoscope for minimally invasive access, visualization and illumination of the target neuro anatomy. The Aurora Surgiscope System consists of two components: the sterile, single use, neurological endoscope called the Aurora Surgiscope […]

Imperative Care Announces FDA Clearance of Initial Products

CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc., a company singularly dedicated to finding answers to unsolved problems in stroke, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its first family of access catheters, designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke and other brain […]