The Latest Cardiac and Vascular News
SILVER SPRING, Md., Sept. 30, 2021 /PRNewswire/ — Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or […]
Full Commercial Launch Underway for One of the Most Studied and Thinnest Strut Drug-Eluting Stents, Offering Enhanced Deliverability LAKE OSWEGO, Ore., Sept. 29, 2021 /PRNewswire/ — BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer drug-eluting stent system (BP-DES). The company also announced the first U.S. […]
Innovative Next-Generation Technology Monitors the Most Important Vital Signs for Cardiovascular Health CHARLOTTESVILLE, Va.–(BUSINESS WIRE)–Caretaker Medical, a pioneer in wireless “beat by beat” continuous, non-invasive, advanced patient monitoring, today announced U.S. Food and Drug Administration (FDA) clearance of the company’s next-generation VitalStream™ wireless blood pressure and hemodynamic monitoring platform. Continuous […]
NEW YORK–(BUSINESS WIRE)–Nanowear, a leading hospital-at-home and remote diagnostic platform informed by proprietary cloth nanotechnology and AI, today announced that it received its third FDA 510(k) clearance and first software-only clearance as an end-to-end digital platform, illustrating unique capabilities available to enterprise customer channels across a broad spectrum of diagnostic […]
This latest milestone helps Zebra-Med expand its mission of screening populations at scale with its AI-based solutions, promoting early and preventative healthcare treatment. The CAC solution analyzes already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with […]
First and only manufacturer-prepared premix formulation of norepinephrine available Offers variety of storage options under refrigeration and at room temperature, allowing drug to be placed closer to patient care settings Ready-to-use format means less chance of compounding errors and touch contamination associated with compounded drug formulations DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International […]
– New enhancements to Abbott’s Epic valve – the most widely used mitral tissue heart valve in the U.S. and globally – can improve implantation and allow compatibility for future transcatheter valve procedures – Epic Plus designed to help patients with more complex cases of aortic or mitral regurgitation or […]
– Transcatheter aortic valve replacement (TAVR) procedure treats people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery – With Portico approval, Abbott offers the industry’s most comprehensive portfolio of structural heart solutions in the U.S. ABBOTT PARK, Ill., Sept. 20, 2021 /PRNewswire/ — Abbott (NYSE: ABT) […]
Company on Schedule to Commence Trial Late This Year VANCOUVER and MINNEAPOLIS, Sept. 16, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received FDA approval for the Investigational Device Exemption (“IDE”) regarding the COSIRA-II IDE Clinical Trial. Following multiple discussions with FDA […]
– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 9, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) granted Breakthrough […]
