The Latest Cardiac and Vascular News
Non-Invasive Technology Requires No Vests, CT or MRI Imaging, or Invasive Mapping SAN DIEGO–(BUSINESS WIRE)–Vektor Medical, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel computational ECG mapping system, vMap™. vMap is designed to map potential arrhythmia sources (hot spots) associated with stable or unstable […]
MINNEAPOLIS–(BUSINESS WIRE)–DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug Administration (FDA) has accepted and concluded that DiaMedica “may proceed” with the proposed clinical investigation using its amended protocol adding stroke […]
12 new hydrophilic-coated micro and support catheters cleared by FDA for broad use in the peripheral vasculature. PARK CITY, Utah, Nov. 2, 2021 /PRNewswire/ — Transit Scientific announced the FDA clearance of new hydrophilic-coated XO Cross Microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature. “The XO Cross devices […]
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 […]
BOSTON, Oct. 20, 2021 /PRNewswire/ — Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that it received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding Stealth’s New Drug Application […]
GENT, Belgium–(BUSINESS WIRE)–FEops today announced that it received De Novo authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion with the Boston Scientific WATCHMAN™ device*. FEops HEARTguide™ will enable physicians to virtually model clinical scenarios with different implant positions and sizes […]
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 […]
