The Latest Cardiac and Vascular News
Triumph™ Catheter and GuideLiner® Coast™ Catheter to be featured at the CTO Plus Conference, February 23-24 in New York, NY WAYNE, Pa., Feb. 22, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced key milestones in the release of two new catheters: the […]
SEOUL, South Korea, Feb. 21, 2023 /PRNewswire/ — Mezzion Pharma Co., Ltd. (Mezzion Pharma) has submitted a confirmatory pivotal Phase 3 Clinical Trial in Fontan subjects to the Food and Drug Administration (FDA). In the Type B meeting between the FDA and Mezzion, the FDA provided Mezzion with a clear path forward […]
– PDUFA Date Set for October 8, 2023 – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (sNDA) for patisiran, an investigational RNAi therapeutic in development for the […]
Irish-based company secures first U.S. regulatory clearance for its Millipede 088 Access Catheter from the Food and Drug Administration (FDA) The company is also developing catheter-based technology for treating acute ischemic stroke GALWAY, Ireland–(BUSINESS WIRE)–Perfuze, a medical device company developing next-generation catheter-based technology to treat acute ischemic stroke, has secured […]
Latest Swoop® software improves image quality for DWI imaging of the brain GUILFORD, Conn., Feb. 13, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. […]
WASHINGTON, Feb. 13, 2023 /PRNewswire/ — MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, Quality Assurance, and Japan Distribution Logistics (DMAH) is pleased to announce its role in the […]
The primary endpoint is the proportion of patients with a good outcome as a modified Rankin Score (mRS) of 0-2 on day 90 post-randomization Sovateltide is an endothelin-B receptor agonist that has been shown to increase blood flow, inhibit apoptosis, and induce neurovascular remodeling WILLOWBROOK, III., Feb. 13, 2023 /PRNewswire/ — Pharmazz, […]
WATERBURY, Conn., Feb. 06, 2023 (GLOBE NEWSWIRE) — Northeast Scientific Inc., the pioneers in reprocessing single use peripheral vascular catheters, announced this week it has received FDA 510(k) clearance for reprocessing the Philips IVUS Eagle Eye Platinum RX Digital catheter. CEO and Founder, Craig Allmendinger shared his thoughts on the […]
DiA Imaging Analysis’s LVivo IQS, a vendor-neutral AI-powered software provides cardiac ultrasound users with real-time image quality feedback while scanning BEER SHEVA, Israel, Feb. 6, 2023 /PRNewswire/ — DiA Imaging Analysis, a leading provider of advanced AI-based software solutions for ultrasound image analysis, announced today that the U.S. Food and Drug Administration (FDA) […]
SCHAFFHAUSEN, CH / ACCESSWIRE / January 31, 2023 / Occlutech Holding AG Occlutech Holding AG (“Occlutech”), one of the world’s leading providers of minimally invasive structural heart disease devices, continues its progress in the US market. The first patient has now been enrolled in the global US study OCCLUFLEX in […]
