Author: Ken Dropiewski

ANI Pharmaceuticals Announces Launch of Mexiletine Hydrochloride Capsules

BAUDETTE, Minn., June 30, 2020 /PRNewswire/ — ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq:ANIP) today announced the launch of Mexiletine Hydrochloride Capsules USP, 150mg, 200mg and 250mg. The current annual U.S. market for this product is approximately $16 million, according to IQVIA/IMS Health. Patrick Walsh, ANI’s Interim President and CEO, stated, “This is our sixth generic […]

Interim Analysis of Recardio’s Phase II Clinical Trial to Be Presented at the 2020 Congress of the European Society of Cardiology

Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that the results of the interim analysis of Recardio’s Phase II clinical trial will be presented at the 2020 Congress of the European Society of Cardiology from August 29 through September 1. SAN FRANCISCO, June 29, 2020 /PRNewswire/ — Entitled […]

New Study Shows Datos Health’s Remote Care Platform Can Increase Patient Adherence to Cardiac Rehabilitation, and Result in Functional Improvement

First-of-its-Kind Clinical Study Indicates Significant Improvement in Exercise Capacity, Suggests Tele-Cardiac Rehab From Home is Viable Alternative to Center-Based Programs TEL AVIV, Israel, June 30, 2020 /PRNewswire/ — Datos Health, provider of hospital-grade automated remote care and telemedicine platforms, announced today the results of new research with Sheba Medical Center, showing that tele-cardiac rehabilitation […]

Medicure Announces Positive Results for AGGRASTAT® in the FABOLUS-FASTER Trial and Publication in the Journal – Circulation

WINNIPEG, MB, June 29, 2020 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company“) (TSXV: MPH) (OTC: MCUJF), a pharmaceutical company, today announced that results from the investigator sponsored FABOLUS-FASTER Phase 4 clinical trial, using AGGRASTAT®, have been published in Circulation, a peer-reviewed journal of the American Heart Association. FABOLUS-FASTER studied different regimens of intravenous […]

MedAlliance Gains CE Mark Approval for Coronary SELUTION SLR™ Sirolimus Drug Eluting Balloon

NYON, Switzerland, June 30, 2020 /PRNewswire/ — MedAlliance has announced the award of its second CE Mark: SELUTION SLR™ 014 PTCA, a novel Sirolimus Drug Eluting Balloon (DEB), for the treatment of coronary arterial disease. This includes indications for both de-novo lesions as well as in-stent restenosis. The approval applies to a broad […]

Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx™ Insertable Cardiac Monitor System

First ICM device with remote programming paired with dual-stage arrhythmia detection algorithm MARLBOROUGH, Mass., June 29, 2020 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-Dx™ Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with […]

Protaryx Medical Announces $8.3M in Funding for First-in-Class Technology for Left Atrial Access in Transcatheter Cardiac Procedures

$5.1M Series A Funding Led by Ajax Health Will Be Used to Develop First-in-Class Product Designed with Three-Dimensional, Independent Steerability to Deliver Reliable Access June 30, 2020 08:00 AM Eastern Daylight Time BALTIMORE–(BUSINESS WIRE)–Protaryx™ Medical, a company committed to reimagining access to the left atrium for transcatheter cardiac procedures, today […]

BioSig Technologies, Inc Closes $17.5 Million Common Stock Offering

Westport, CT, June 29, 2020 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”) and its majority-owned subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it has closed on the sale of 2,187,500 shares of the Company’s common stock, at a purchase price of $8.00 per share, in a registered […]

Intact Vascular Announces Positive One-Year Data from TOBA II BTK Clinical Trial in VIVA Late-Breaking Session

Durable Below-the-Knee Vascular Implant for Post-Angioplasty Dissection Repair Demonstrates Sustained Success Saving Limbs WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the positive one-year results from its Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical […]