The Latest Cardiac and Vascular News
The U.S. STAR-D and already recruiting STAR-T randomized controlled pivotal trials are intended to establish DrugSorb-ATR as a single, easy-to-use solution for the reduction of perioperative bleeding in open heart surgery patients caused by the most widely prescribed next generation antiplatelet and anticoagulant drugs MONMOUTH JUNCTION, N.J., Oct. 12, 2021 /PRNewswire/ — CytoSorbents […]
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 […]
Rotarex™ Rotational Excisional Atherectomy System is the first and only atherectomy and thrombectomy device indicated to treat in-stent restenosis in the United States FRANKLIN LAKES, N.J., Oct. 6, 2021 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has received 510(k) clearance for expanded indications from the […]
MARLBOROUGH, Mass.–(BUSINESS WIRE)–GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to remove hypersensitivity to ‘blood and blood products’ from the contraindications in its prescribing information for its product OptisonTM (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). Optison is an ultrasound enhancing agent […]
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 […]
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 […]
