The Latest Cardiac and Vascular News
The Company filed a 510(k) premarket notification for its prescription-only medical device to be used in-home for babies under the supervision of a physician LEHI, Utah–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”) for […]
PALO ALTO, Calif., Sept. 22, 2022 /PRNewswire/ — DyAnsys, Inc., has announced that Primary Relief, a percutaneous electrical neurostimulation device, has been approved to treat pain following a cardiac surgery. The percutaneous electrical nerve stimulator (PENS) system can be used for up to three days for symptomatic relief of post-operative pain following […]
Breakthrough Designation Reinforces Significant Unmet Need in Treatment of Small Vessel Coronary Arteries LOS GATOS, Calif., Sept. 19, 2022 /PRNewswire/ — Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease’s most significant challenges through the creative applications of nanotechnology, today announced the U.S. Food and Drug Administration (FDA) has […]
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 […]
