The Latest Cardiac and Vascular News
Completion of patient enrolment expected before end of year Primary endpoint read-out due in Q4 2022 59 patients already recruited in the Pivotal Cohort Ghent, Belgium – 4 October 2021 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an […]
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 […]
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 […]
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 […]
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 […]
– 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, […]
ANDOVER, Mass., Sept. 7, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has […]
Evolut™ FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment DUBLIN, Aug. 24, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter […]
XARELTO® is the first and only therapy indicated for both coronary artery disease (CAD) and PAD, now including PAD patients post-LER XARELTO® is the only anticoagulant in 20 years to show significant benefit in patients with PAD who remain at […]
No Form 483 observations were issued during 5-day inspection MORRISVILLE, N.C., Aug. 18, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has completed an on-site Pre-Approval Inspection (PAI) of its […]
