The Latest Cardiac and Vascular News
HALIFAX, Nova Scotia, Sept 12, 2022 – ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces FDA 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumors. Arteriovenous malformations (AVMs) […]
This is the second Fast Track designation issued by the FDA for abelacimab Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and Factor XIa with high affinity and selectivity CAMBRIDGE, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) — Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for […]
US Arm of IMPACT II Study Will Ascertain Reduction of Esophageal Thermal Injury During Cardiac RF Ablation Procedures CHICAGO–(BUSINESS WIRE)–The US Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to Attune Medical to evaluate the company’s ensoETM in the reduction of esophageal thermal injury during cardiac radiofrequency ablation […]
SOUTH SAN FRANCISCO, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, announced clearance of its Investigational New Drug (IND) application to begin clinical testing of […]
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation systems to treat ventricular arrhythmias, announced today that the U.S. Food & Drug Administration (FDA) has approved an open-label, single-arm interventional clinical trial to evaluate the safety and efficacy of the Thermedical® SERF Ablation System with the Durablate® Catheter in people with ventricular tachycardia (VT) resistant to […]
Submission Seeks Approval for the Company’s Proprietary ECG Technology to Aid in Diagnosis of Heart Attack in $500 million Total Addressable Market 18+ million People in the US have Coronary Artery Disease and Heart Attacks Occur Every 40 Seconds SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital […]
Medicalgorithmics has received FDA approval in the U.S. for its proprietary next generation system in ECG signal analysis called DeepRhytmAI. WARSAW, Poland, Aug. 10, 2022 /PRNewswire/ — It is a cloud-based Artificial Intelligence algorithm that classifies ECG signals. Without excessive human involvement, DeepRhytmAI is able to recognize a wide range of arrhythmia disorders […]
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 […]
