Posts by cstephenson@legacymedsearch.com
Abbott’s TriClip Becomes First Device of its Kind to Receive CE Mark for Minimally Invasive Tricuspid Valve Repair
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…
Read MoreU.S. FDA Grants CytoSorb Emergency Use Authorization for Use in Patients with COVID-19 Infection
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…
Read MoreFDA Grants Breakthrough Device Designation to DNAe’s Sequencing Diagnostic
DNAe, the next generation sequencing company developing novel diagnostics for use at the point-of-need, today announced that the US Food and Drug Administration (FDA) has granted it a “Breakthrough Device” designation for its pioneering platform and first assay. DNAe has reinvented sequencing in order to develop a compact device operable by non-specialist users. LiDia-SEQ™ will,…
Read MoreSpiderTech Helping Healthcare Workers Experiencing Irritation, Sores From PPE With Face Protection
In the midst of the COVID-19 pandemic, healthcare workers across the world have been active on social media displaying the painful results of wearing medical personal protective equipment (PPE) for long hours on the job. Face masks, surgical and N95 masks, eyewear, facial hoods and other protective measures have resulted in red, sore, irritated skin…
Read MoreFDA Grants Vapotherm Oxygen Assist Module (OAM) Breakthrough Device Designation
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…
Read MoreStryker Releases Emergency Relief Bed, a Limited-Release Medical Bed to Support Critical Needs During Pandemic
Stryker, one of the world’s leading medical technology companies, announced today it has developed a low-cost, limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. “People are at the heart of what we do, and COVID-19 hasn’t changed that. It has amplified our mission of making healthcare better.…
Read MorePrecision Spine Announces the Worldwide Launch of the Reform Ti Pedicle Screw System Providing Surgeons with Increased Flexibility, Versatility, and Visibility
Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched world wide the Reform® Ti Titanium Pedicle Screw System, which provides surgeons with the increased flexibility, versatility, and visibility that is required during today’s challenging degenerative and trauma spine procedures. The Reform Ti System features a titanium tulip and a triple lead thread to…
Read MoreAllurion Technologies Announces Submission of US Premarket Approval Application for its Flagship Elipse Gastric Balloon
Allurion Technologies, an established leader in the development of innovative, proven, and trusted weight loss experiences, today announced the Premarket Approval (PMA) submission of its flagship Elipse gastric balloon. The company had previously announced the successful completion of its landmark FDA pivotal study and the hiring of key personnel who will be leading the US market launch. These milestones…
Read MoreCOVID-19 Antibody Test Released by Ortho Clinical Diagnostics
Aligned with its mission to improve and save lives with diagnostics, Ortho Clinical Diagnostics today announced it is launching to market its SARS-CoV-2 (COVID-19/coronavirus) antibody test—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. Testing kits are expected to be available in a few weeks. Ortho followed the guidelines established by the U.S. Food and Drug Administration’s…
Read MoreSpectrum Solutions Saliva Collection Device Answers Critical Testing Hurdles, Enabling Large-Scale COVID-19 Testing While Protecting Health Professionals From Exposure
Spectrum DNA™, a division of Spectrum Solutions, LLC, in Salt Lake City, Utah, today announced that using the Spectrum DNA SDNA-1000 Whole Saliva Collection Device, researchers from RUCDR Infinite Biologics at Rutgers University have successfully validated saliva as being a viable biosample source for COVID-19 detection when compared to nasopharyngeal or oropharyngeal swabs. The resourceful…
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