The Latest Cardiac and Vascular News
The Oxford, UK headquartered company, long established as a market leader in Europe and a pioneer in the development of innovative stroke AI solutions, is now poised to take its transformative technology to US stroke centers OXFORD, England, and CHICAGO, March 21, 2023 /PRNewswire/ — Brainomix, the […]
SILVER SPRING, Md., March 20, 2023 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, provides an update on its submission […]
Pivotal study expected to be completed by year-end 2023 and set the stage for commercialization of PerQseal® system for large hole vessel closure Company announces €30 million strategic investment from Haemonetics as part of its previously disclosed Series D financing GALWAY, Ireland–(BUSINESS […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Essenz™ Heart-Lung Machine (HLM). With FDA clearance, LivaNova initiates the commercial launch of Essenz […]
Complete Response Letter States that GALACTIC-HF Alone Does not Establish Substantial Evidence of Effectiveness Sufficient for Approval Company Expects to Request Meeting with FDA to Discuss Potential Next Steps Cytokinetics to Host Conference Call and Webcast on March 1, 2023 at […]
Swoop® Portable MR Imaging® system positioned to offer even greater clinical utility in neurocritical care GUILFORD, Conn., Feb. 28, 2023 (GLOBE NEWSWIRE) — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first […]
Integrated with the Rapid PE solution, Rapid RV/LV further accelerates time to triage and diagnose pulmonary embolism patients with right heart strain SAN MATEO, Calif.–(BUSINESS WIRE)–RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today […]
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 […]
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 […]
– 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) […]
