Author: Ken Dropiewski

Merit Medical Launches One-Vac™ Evacuated Drainage Bottle for Percutaneous Fluid Collection and Discard

Advanced design makes sample collection simple, efficient, and safe SOUTH JORDAN, Utah, Aug. 16, 2021 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy, […]

Humacyte Announces Addition of Chief Commercial Officer and Integration of Commercial-Scale Manufacturing into Clinical Trial Programs

Appoints proven commercial leader B.J. Scheessele as Chief Commercial Officer In-house Durham, N.C. facility is operational and supplying clinical trial material produced in commercial-scale manufacturing system Company’s proprietary modular manufacturing systems can produce an estimated 40,000+ vessels annually in current facility when scaled up DURHAM, N.C., Aug. 17, 2021 (GLOBE […]

Tenax Therapeutics Reports Second Quarter 2021 Results and Provides Business Update

MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today reported financial results for the second quarter of 2021 and provided a business update. “We are entering an exciting period […]

Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.

SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ — Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by […]

ABBOTT’S AMPLATZER™ AMULET™ DEVICE APPROVED BY FDA TO TREAT PEOPLE WITH ATRIAL FIBRILLATION AT RISK OF STROKE

– Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left atrial appendage (LAA), so blood-thinning medication isn’t needed following implantation – The device helps to prevent blood clots from forming and leaving the LAA, reducing the risk of stroke in patients with […]

Ultromics Raises $33M in Series B Funding to Help Transform Cardiac Disease Treatment

Led by Blue Venture Fund, new funding will accelerate Ultromics’ use of AI-enabled echocardiograms to improve patient outcomes OXFORD, England, Aug. 16, 2021 /PRNewswire/ — Ultromics, a leader in AI enabled cardiovascular imaging solutions, announced today that it has raised $33 million in a Series B funding round. The round was led by the […]

NeuroBo Pharmaceuticals Reports Second Quarter 2021 Financial Results

BOSTON, Aug. 16, 2021 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on developing and commercializing multimodal disease-modifying therapies for viral, neuropathic and neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2021. Management Commentary “During the second quarter, we continued to advance the Phase 2/3 clinical trial […]

Eko Brings Cardiopulmonary Focus to the Frontline of Care With the Next Generation DUO

The pocket-sized cardiac examination system helps clinicians of all types detect heart disease earlier OAKLAND, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) — Eko, a cardiopulmonary digital health company, today announced the launch of the next generation Eko DUO. DUO is the first FDA-cleared cardiac assessment tool that functions as an electrocardiogram (ECG) […]

JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

IRVINE, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk […]