Author: Ken Dropiewski

Cardiovascular Systems, Inc. Reports Fiscal 2019 Third-Quarter Financial Results

ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today reported financial results for its fiscal third quarter, ended March 31, 2019. CSI’s third-quarter revenues were $63.3 million, an increase of […]

First-of-its-Kind Large Access Dilator Launches in U.S., Following Cleveland Clinic Case

TORONTO, May 2, 2019 /PRNewswire/ – Baylis Medical announced today the U.S. launch and first clinical use of its ExpanSure™ Transseptal Dilation System, used in a left-atrial appendage (LAA) closure case performed at the Cleveland Clinic, in Cleveland, Ohio. The ExpanSure dilator combines a sheath and dilator into a single tool, and facilitates larger […]

Concept Medical Inc. Granted ‘Breakthrough Device Designation’ From FDA for Its MagicTouch Sirolimus Coated Balloon

TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to […]

FDA Approves Initiation of STEMI DTU Pivotal Randomized Controlled Trial

DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive […]

Medtronic Receives FDA Approval for CareLink SmartSync Device Manager

DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]

Sotera Wireless to Showcase Its Life-Saving ViSi Mobile 1.5G at the 2019 IHI Patient Safety Congress

SAN DIEGO–(BUSINESS WIRE)–Sotera Wireless, maker of the ViSi Mobile® Surveillance Monitoring System will be exhibiting at the Institute for Healthcare Improvement Patient Safety Congress (IHI) on May 15-17 in Houston, TX. The IHI Patient Safety Congress brings together people who are passionate about providing the highest quality care and patient […]

GENETIC-AF Phase 2B Trial Results Published in the Journal of American College of Cardiology: Heart Failure

WESTMINSTER, Colo., May 01, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that the paper “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population” was published in JACC: Heart Failure, a journal […]

Biofourmis’ RhythmAnalytics™ Platform Receives FDA Clearance for AI-Based Automated Interpretation of Cardiac Arrhythmias

BOSTON, April 30, 2019 /PRNewswire/ — Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which […]

Zynex Announces 2019 First Quarter Earnings

ENGLEWOOD, Colo., April 30, 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 reported financial results for its first quarter ended March 31, 2019. First Quarter Financial Results Summary:For the first […]