The Latest Cardiac and Vascular News
US Based Pilot Study to enroll patients who develop communicating hydrocephalus following subarachnoid hemorrhage BOSTON, Aug. 9, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption […]
AI-powered Viz SDH automatically detects subdural hemorrhage, enables effective triage and optimal care SAN FRANCISCO–(BUSINESS WIRE)–Insert after fourth paragraph of release: footnote 2. The updated release reads: VIZ.AI RECEIVES FDA 510(K) CLEARANCE FOR VIZ SDH AI-powered Viz SDH automatically detects subdural hemorrhage, enables effective triage and optimal care Viz.ai, the […]
TIGERTRIEVER™13 is designed to reduce vessel tension during ischemic stroke treatment YOKNEAM, Israel & TORONTO–(BUSINESS WIRE)–Rapid Medical, a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER™13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. TIGERTRIEVER 13 is the smallest revascularization device in […]
NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program Evaluating Sotagliflozin in Almost 12,000 People THE WOODLANDS, Texas, July 27, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and filed its New Drug Application (NDA) for […]
The new solution allows for quick identification of hyperdense volumes to improve hemorrhage management SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA clearance for Rapid Hyperdensity, the newest addition to the RapidAI platform. The tool empowers […]
Designation Allows for Expedited Review of Transcatheter Therapy Designed to Improve Left Ventricular Structure and Function in Heart Failure Patients with Reduced Ejection Fraction SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration […]
First and only machine learning algorithm to assist healthcare professionals in identifying structural heart murmurs using a smart stethoscope OAKLAND, Calif., July 12, 2022 /PRNewswire/ — Eko, a digital health company advancing heart and lung disease detection, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Eko Murmur Analysis […]
Abelacimab is a dual-acting fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity Earlier this year abelacimab became the first-ever Factor XI inhibitor to begin enrolling patients in a Phase 3 trial (The ASTER Study) The AZALEA-TIMI 71 trial in patients with atrial fibrillation […]
Board of Directors continues its review of strategic alternatives to determine the Company’s optimal path forward CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”), a medical device company focusing on developing its excimer laser system to treat vascular diseases, announces receipt of U.S. Food and […]
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardio Flow, Inc., a medical device company and developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. The FreedomFlow guidewire is stainless steel core-to-tip design […]
