Author: Ken Dropiewski

FDA Grants Breakthrough Device Designation Status for BioVentrix Revivent TC Transcatheter Ventricular Enhancement System for Heart Failure

SAN RAMON, Calif.–(BUSINESS WIRE)–BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular Enhancement System for heart failure. Less Invasive […]

Prevencio Announces Highly Accurate, AI-driven Blood Test with High Sensitivity (hs) Cardiac Troponin for the Diagnosis of Heart Disease

HART CADhs test addresses up to 30% of Emergency Department (ED) chest pain patients who cannot safely be ruled-in nor ruled-out for heart attack KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc. today announces data confirming the high accuracy of its AI-driven, multiple-protein HART CADhs test, a biomarker clinical/proteomic panel inclusive of high sensitivity cardiac […]

Neovasc Tiara™ Progress Highlighted at PCR London Valves 2019

VANCOUVER, Nov. 19, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that its transfemoral trans-septal (“TF/TS”) Tiara™ […]

Amarin Highlights Key REDUCE-IT®-Related Data Presented at American Heart Association 2019 Scientific Sessions

REDUCE-IT USA results, in prespecified subgroup analyses, showed cardiovascular risk reductions across all endpoints, including 30% relative risk reduction  in all-cause mortality New analysis determined icosapent ethyl (Vascepa®) is highly cost-effective in patients from the REDUCE-IT study and, as is rarely found, may result in net healthcare cost-savings to patients, payers […]

Faraday Pharmaceuticals Announces Positive Top-Line Results from Phase 2 Trial of FDY-5301 for Treatment of Reperfusion Injury Following a STEMI Heart Attack

Treatment well tolerated, with encouraging signs to support pivotal trial Results presented at American Heart Association Scientific Sessions 2019 SEATTLE, Nov. 19, 2019 /PRNewswire/ — Faraday Pharmaceuticals, a biopharmaceutical company focused on the development of small molecules for critical care medicine, today announced top-line results from its Phase 2 trial of FDY-5301 for […]

BioSig Technologies Welcomes the Creation of New Bioelectronic Medicine Alliance

BioSig Supports the Alliance for Advancing Bioelectronic Medicine, Which Seeks to Bring Together Leading Experts to Advance Entire Field Westport, CT, Nov. 18, 2019 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or “The Company”), a medical technology company developing a proprietary biomedical signal processing platform designed to improve […]

Clinical Review Demonstrates Cost-Effectiveness of Impella in High-Risk PCI and Cardiogenic Shock

DANVERS, Mass.–(BUSINESS WIRE)–To mark the five year anniversary of the study by Stretch, et al., on cost and outcomes trends for short-term mechanical circulatory support, Abiomed announces a comprehensive publication review of cost and comparative effectiveness of Impella in high-risk PCI and cardiogenic shock. The data, from a robust body of US and European […]

Zynex Ranked 18th in Revenue Growth Among Medical Device Companies

ENGLEWOOD, Colo., Nov. 14, 2019 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced it has been ranked 18th in revenue growth among all medical device companies in the U.S. and Canada on Deloitte’s 2019 […]

Amgen Announces New FOURIER Analysis Showing Benefit Of Repatha® (evolocumab) In High-Risk Patients Who Have Experienced A Recent Heart Attack

Additional FOURIER Analysis Shows Lowering LDL-C With Repatha Did Not Impair Patient-Reported Cognition THOUSAND OAKS, Calif., Nov. 16, 2019 /PRNewswire/ — Amgen today announced a new analysis from the Repatha® (evolocumab) cardiovascular outcomes (FOURIER) study that evaluates the effectiveness of Repatha in patients who have suffered a recent myocardial infarction (MI). The analysis showed […]