FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation 

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Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. The FDA’s Breakthrough Device Designation Program is intended to provide timely access to medical devices that have the potential to provide a…

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Synapse Biomedical’s TransAeris Diaphragm Pacing System Gets FDA Emergency Use Authorization for Quicker Ventilator Weaning

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Synapse Biomedical, Inc. has received an Emergency Use Authorization for the emergency use of its TransAeris® DPS, to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off of ventilators in healthcare settings during the COVID-19 pandemic for no more than 30 days. During the COVID-19 pandemic, the…

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Tack Endovascular System Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair

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Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries. Regulatory approval was based on data from…

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Abbott’s TriClip Becomes First Device of its Kind to Receive CE Mark for Minimally Invasive Tricuspid Valve Repair

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Abbott announced that its TriClip™ Transcatheter Tricuspid Valve Repair System has received CE Mark and is now approved for use in Europe and other countries that recognize CE Mark as a non-surgical treatment for people with a leaky tricuspid valve, a condition known as tricuspid regurgitation (TR). With the CE Mark designation, Abbott’s TriClip device is…

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U.S. FDA Grants CytoSorb Emergency Use Authorization for Use in Patients with COVID-19 Infection

cytosorb medical device

CytoSorbents Corporation, a  critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 infection. Under the EUA, CytoSorbents can make CytoSorb available, through…

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FDA Grants Vapotherm Oxygen Assist Module (OAM) Breakthrough Device Designation

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Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients of all ages suffering from respiratory distress, today announced that the U.S. Food and Drug Administration (FDA) recently granted Breakthrough Device Designation for the Company’s Oxygen Assist Module (OAM). FDA’s…

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FDA Clears Siemens Healthineers RAPIDPoint 500e Blood Gas Analyzer Used for Critically Ill Patients in Acute Care Settings

Siemeins Healthineers

Siemens Healthineers announced today that its latest critical care testing solution, the RAPIDPoint® 500e Blood Gas Analyzer, has received clearance from the U.S. Food and Drug Administration. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating…

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CardioQuip MCH-1000 Earns CE Mark Approval

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CardioQuipTM, LLC, a medical device manufacturer focused on development and commercialization of patient temperature control and cardiovascular perfusion technology announced today it has received CE Mark approval for the MCH-1000TM Modular Cooler-Heater SeriesTM. The MCH-1000 Series of cooler-heaters is now available to European hospital systems fighting the COVID-19 pandemic. A cooler-heater device is used to regulate patient temperature…

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VERO Biotech Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide

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VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS at home. The patient was treated under an emergency IND…

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TriGUARD 3 Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Keystone TriGUARD

Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3™ Cerebral Embolic Protection (CEP) Device. The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures. “Even with increased operator experience…

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