SCHAFFHAUSEN, Switzerland, Sept. 6, 2019 /PRNewswire/ — Occlutech AG announced today that its atrial flow regulator, the Occlutech AFR device, has obtained CE mark approval clearing it for sales on the European CE regulated market. Occlutech AFR is a next generation intra-atrial shunt device, intended to treat heart failure symptoms by decompressing abnormal […]
Other News
IN.PACT AV Access Trial Meets Primary Safety and Effectiveness Endpoints
IN.PACT AV Drug-Coated Balloon Shows Promise in Treating Arteriovenous Fistulae Lesions in End-Stage Renal Disease Patients DUBLIN and BARCELONA, Spain, Sept. 07, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) announced the first-ever results from the IN.PACT AV Access clinical study comparing the investigational IN.PACT™ AV™ drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) in patients with […]
Vascular Therapies Announces Positive Preliminary Clinical Results from its AV Fistula Trials in Patients with Kidney Disease
CRESSKILL, N.J., Sept. 9, 2019 /PRNewswire/ — Vascular Therapies, a clinical stage biotechnology company, is developing Sirogen™, a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery focused on improving vascular access outcomes in patients with kidney disease. Daniel G. Clair, MD, vascular surgeon and Chairman of the Department of Surgery at Palmetto Health-USC […]
BIOLIFE4D Becomes First U.S. Company to Successfully Demonstrate Ability to 3D Bioprint a Mini Human Heart
Pioneering biotech company reaches significant milestone, using proprietary bioink to successfully 3D bioprint a mini-heart with full structure of a whole heart, including chambers and ventricles CHICAGO, Sept. 09, 2019 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today […]
Two new Pfizer-coauthored studies validate Novoheart’s pioneering human bioengineered heart tissues and chambers for improving drug development
September 09, 2019 00:05 ET | Source: Novoheart Holdings Inc. Novoheart seeks to revolutionize human heart tissue engineering for disease modeling and drug discovery Peer-reviewed publications feature results from the completion of two research contracts between Novoheart and Pfizer Novoheart’s proprietary MyHeartTM Platform of human bioengineered heart tissues can represent healthy as well as […]
SoniVie Receives FDA Breakthrough Device Designation for the TIVUS System in the Treatment of Pulmonary Arterial Hypertension (PAH)
– Designation facilitates more rapid approval and reimbursement for a breakthrough technology that offers significant advantages over current PAH treatment options – TEL AVIV, ISRAEL (PRWEB) SEPTEMBER 06, 2019 SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device […]
Netech Obtains FDA 510(k) Clearance for Delta 3300 – Defibrillator/Pacemaker Analyzer
FARMINGDALE, N.Y., Sept. 9, 2019 /PRNewswire/ — Leading biomedical test-instrument manufacturer Netech announced today the launch of its new state-of-the-art defibrillator/pacemaker analyzer—the Delta 3300. Recently approved by the FDA 510(k), the Delta 3300 is a precision instrument for testing and validating the functions of all semi and automated defibrillators. This revolutionary compact, […]
Recardio’s Phase 2 Regenerative Post-Myocardial Infarction Trial of Dutogliptin Now Enrolling and Recruiting in All Global Centers
Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that its Phase 2 study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction is now enrolling and recruiting in all multiple European and U.S. centers. SAN FRANCISCO, Sept. 9, 2019 /PRNewswire/ — The clinical study is intended […]
AngioDynamics Awarded Premier’s Nationally Outsourced Implantable Infusion Port Agreement
LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that the Company has been awarded a dual-source group purchasing agreement by Premier, Inc. to supply implantable infusion ports. The three-year agreement becomes effective on […]
Acceleron Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary Arterial Hypertension
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary […]



