The Latest Cardiac and Vascular News
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 […]
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 […]
