The Latest Cardiac and Vascular News
IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). Over […]
Magenta Medical initiates its Early Feasibility Study in leading NY cardiology centers KADIMA, Israel, June 7, 2023 /PRNewswire/ — Magenta Medical, developer of the world’s smallest heart pump, announced today the initiation of its FDA-approved Early Feasibility Study with the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk percutaneous coronary intervention (HR-PCI) […]
Company expands Structural Heart Portfolio with the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve replacement (TAVR) and balloon aortic valvuloplasty (BAV) WAYNE, Pa., June 07, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced […]
IRVINE, Calif, June 7, 2023 /PRNewswire/ — Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever™ System and its Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two new devices are collectively known as the Laguna Thrombectomy System. […]
First and Only IO Needle with MR Conditional Safety Status Labeling WAYNE, Pa., June 06, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, today announced that the Arrow® EZ-IO® Needle is the first and only Intraosseous (IO) Needle to receive […]
Sonic DLi is a deep learning (DL) technology that acquires high-quality magnetic resonance (MR) images up to 12 timesii faster than conventional methods, enabling cardiac imaging within a single heartbeat When applied to cardiac MRI, Sonic DL extends access to cardiac patients with arrhythmias and breath-holding challenges, helping to ensure swift, consistent, […]
Breakthrough SaaMD enables smartphones to be used as class-leading stethoscopes that capture, analyze and share cardiovascular and pulmonary sound data ST. JOHN’S, Newfoundland–(BUSINESS WIRE)–Sparrow BioAcoustics today announced it has received clearance from the U.S. Food and Drug Administration to market its software that allows smartphones to be used as medical stethoscopes. […]
This is the first and only single tablet combination therapy application to be submitted for review in the U.S. for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guidelines-recommended treatment pathways RARITAN, N.J., May 30, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson […]
The FDA has provided valuable feedback to reinforce the proposed clinical development plan of glenzocimab in acute ischemic stroke (AIS) A new Type C consultation with the FDA has been granted on the pharmaceutical development plan In Europe additional scientific advice requests under the PRIME program have been validated by […]
INPEFA granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes INPEFA reduced the risk of total occurrence of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits by 33% compared to placebo in the SOLOIST-WHF […]
