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 to the U.S. Food and Drug Administration (FDA) for the […]
Regulatory
Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study
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 WIRE)–Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel […]
LivaNova Receives U.S. FDA 510(k) Clearance for Essenz Heart-Lung Machine for Cardiopulmonary Bypass Procedures
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 in the U.S. The Company also recently received approval for […]
Cytokinetics Receives Complete Response Letter From FDA for New Drug Application for Omecamtiv Mecarbil
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 8:30 am Eastern Time SOUTH SAN FRANCISCO, Calif., Feb. 28, […]
Hyperfine, Inc. Receives FDA Clearance for Updated Software to Further Improve Diffusion-Weighted Imaging
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 FDA-cleared portable MRI system, today announced the U.S. Food and […]
RapidAI Enhances Pulmonary Embolism Care Solution with FDA 510(k) Clearance for Rapid RV/LV
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 announced it has received FDA 510(k) clearance for Rapid RV/LV, […]
Teleflex Expands Interventional Cardiology Portfolio with Two New FDA-Cleared Catheter Devices for Use in Complex Percutaneous Coronary Interventions (PCI)
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 […]
Mezzion Pharma Submits Protocol for Confirmatory Pivotal Phase 3 Trial (“FUEL-2”) in Fontan Subjects
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 […]
Alnylam Announces U.S. Food and Drug Administration (FDA) Acceptance of Supplemental New Drug Application for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis
– 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 […]
Perfuze Announces FDA Clearance and First U.S. Clinical Use of Millipede 088 Access Catheter
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 […]
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