DUBLIN – April 9, 2018 – Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin an investigational device exemption (IDE) pivotal trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood pressure (hypertension). Renal denervation is a minimally invasive procedure intended […]
Author: Ken Dropiewski
Fischer Medical Receives U.S. FDA 510(k) Clearance to Market Bloom2 Cardiac Stimulator
DENVER, April 9, 2018 /PRNewswire/ — Fischer Medical has announced that the Bloom2 cardiac electrophysiology stimulator device has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Bloom2stimulator is a fundamental component of nearly all electrophysiology (EP) procedures to diagnose and treat cardiac rhythm disorders. The release of the digital version of […]
Canon Medical Systems’ Aquilion Precision Receives FDA Clearance
TUSTIN, Calif.–(BUSINESS WIRE)–Canon Medical Systems USA, Inc.’s newly FDA-cleared Aquilion Precision™ is the world’s first Ultra-High Resolution CT system (UHR CT). The system can resolve anatomy as small as 150 microns and is designed to provide more than twice the resolution, typically seen only in cath labs. Containing an all-new detector […]
LivaNova Completes Acquisition of TandemLife
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, today announced it closed its acquisition of TandemLife. Previously, on Feb. 14, LivaNova announced its intent to acquire TandemLife, a privately held company focused on advanced cardiopulmonary temporary support solutions. “The acquisition of TandemLife allows us to […]
Sotera Medical Secures Seed Financing
CLEVELAND–(BUSINESS WIRE)–Sotera Medical Corp., a medical device company developing a novel device for use in cardiac procedures to treat atrial fibrillation, has closed initial seed funding in excess of one million dollars. The round was led by a syndicate of investors, including JumpStart Inc., North Coast Angel Fund, Northwest Ohio […]
Cardiva Medical® Announces FDA Approval of VASCADE® Vascular Closure System for Use in Femoral Vein Closure
SANTA CLARA, Calif.–(BUSINESS WIRE)–Cardiva Medical®, an innovator in the field of vascular closure, today announced the company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication of the VASCADE® Vascular Closure System. Already approved for use in arterial closure, VASCADE is now FDA approved […]
AliveCor Data Yield Reaches 25MM ECGs
MOUNTAIN VIEW, Calif., April 5, 2018 /PRNewswire/ — AliveCor, the leader in FDA-cleared personal electrocardiogram (ECG) technology, announced today that it had surpassed the milestone of 25 million recorded ECGs – by far the largest data set ever collected by any consumer ECG. The company also announced that its KardiaBand product, paired with […]
CARMAT: Continuing Progress in Line with the Objective of Obtaining CE Marking in 2019
PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart project, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announced an update on the progress of the PIVOTAL study and the latest developments regarding […]
Abiomed (ABMD) Reports European Approval (CE Marking) for Impella 5.5 & 1st Patient Treated at University Heart Center Hamburg
Abiomed, Inc. (NASDAQ: ABMD) announced today that the Impella 5.5™ heart pump received CE marking1 approval in Europe and the first patient was treated at University Heart Center in Hamburg, Germany. The Impella 5.5 heart pump further enhances Abiomed’s product portfolio and provides physicians a 30-day, ambulatory, wean-able, forward flow heart pump. […]
Paragonix Technologies, Inc. Announces Presentation of the SherpaPak™ Cardiac Transport Systems and SherpaPerfusion™ Cardiac Transport System at the 38th Annual Meeting of the International Society for Heart and Lung Transplantation
BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. will present the SherpaPak™ Organ Transport product line at Booth 14 during the 38th Annual Meeting of the International Society for Heart and Lung Transplantation (ISHLT) (Nice, France, 11-14 April 2018). The SherpaPak™ Organ Transport product line1,2 combines innovative cooling technology with safe, consistent methods for cold […]
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