Other News

CytoSorbents Gets FDA Greenlight For Pivotal Study of CytoSorb in Cardiac Surgery

MONMOUTH JUNCTION, N.J., Dec. 21, 2017 /PRNewswire/ — CytoSorbents (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its flagship CytoSorb® blood filter to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the U.S. Food and Drug Administration (FDA) has granted approval of its REFRESH 2 Investigational Device Exemption […]

BioSig Technologies Issues Shareholder Letter for 2017

Santa Monica, CA, Dec. 21, 2017 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has officially issued a letter to its shareholders […]

Avinger Announces 510(k) Filing of Next Generation Pantheris Device

REDWOOD CITY, Calif., Dec. 21, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), announced the Company submitted a new 510(k) application to the U.S. Food & Drug Administration (FDA) for its next generation Pantheris® Lumivascular atherectomy system, the first-ever image-guided […]

Boston Scientific to Participate in Goldman Sachs Healthcare CEOs Unscripted Conference

MARLBOROUGH, Mass., Dec. 21, 2017 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) is scheduled to participate in the Goldman Sachs Healthcare CEOs Unscripted Conference on Thursday, January 4, 2018 in Boston, MA. Mike Mahoney, chairman and chief executive officer, will participate in a 30-minute question-and-answer session with the host analyst beginning at approximately 9:30 a.m. A live webcast […]

FDA Grants RMAT Designation For Mesoblast’s Cell Therapy in Heart Failure Patients With LVADs

NEW YORK and MELBOURNE, Australia, Dec. 21, 2017 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for its novel mesenchymal precursor cell (MPC) therapy in the treatment of heart failure patients with left ventricular […]

Mentice Acquires Endovascular Business from Medical Simulation Corporation

GOTHENBURG, Sweden–(BUSINESS WIRE)–Mentice boosts its US development presence and adds a clinical training service line with the acquisition of Medical Simulation Corporation’s (MSC) Medical Products division. Mentice is the global leader of simulation-based performance solutions for endovascular therapies. Under the agreement, Mentice will acquire the assets of the MSC’s Medical […]

Impulse Dynamics’ Optimizer® Receives CFDA Approval in China

ORANGEBURG, New York and STUTTGART, Germany, December 18, 2017 /PRNewswire/ —  The China Food and Drug Administration (CFDA) has approved Impulse Dynamics’ Optimizer® system for treatment of chronic heart failure. The announcement was made on December 12, 2017 by Impulse Dynamics’ CEO, Dr. Simos Kedikoglou. “This is a major milestone for Impulse Dynamics, as it will help us […]

Avinger Receives CE Marking Approval for Next Generation Pantheris Image-Guided Atherectomy Device

REDWOOD CITY, Calif., Dec. 20, 2017 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced Conformité Européenne (CE) Marking approval for its next generation Pantheris Lumivascular atherectomy system, the first-ever image-guided atherectomy device for the treatment of PAD. The novel […]

For Heart Disease Patients, Better Outcomes are Tied to Tying the Knot

by Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) Marriage is the age old punch line to bad jokes about dying early, before your time. But new studies indicate that, for some, marriage actually extends life and improves outcomes! The study, by Arshed Quyyumi, of Emory University in Atlanta reports that heart disease […]

XableCath Scores FDA Clearance for Broadly Effective Catheter

SALT LAKE CITY–(BUSINESS WIRE)– XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the FDA. The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can […]