The Latest Cardiac and Vascular News
FDA Authorizes Removal of “NSR” From Indications for Use MARLTON, N.J., Oct. 26, 2021 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), today announced that the U.S. Food and Drug Administration approved a modification of labeling for […]
ScanWatch becomes the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist ISSY-LES-MOULINEAUX, France, Oct. 12, 2021 /PRNewswire/ — Today, Withings, pioneers of the connected health revolution, is pleased to announce ScanWatch, its globally acclaimed and most medically advanced wearable, […]
Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years SAN JOSE, Calif., Oct. 7, 2021 /PRNewswire/ — Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced FDA 510(k) clearance for Venclose Maven™, a novel radiofrequency ablation […]
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 innovator in the treatment of diuretic-resistant fluid overload in liver […]
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. […]
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 […]
– 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 […]
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 granted premarket approval (PMA) of its OCS Heart System for […]
