Arkis BioSciences announces it has received ISO 13485:2016 certification for its medical device quality management system by TÜV USA, Inc. (Member of TÜV NORD Group). Receiving the ISO certification indicates Arkis’ quality management system meets the most current international regulatory requirements necessary for global sales within the medical device industry. “This certification demonstrates our ongoing […]
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Arkis BioSciences News
Arkis BioSciences® exhibited at the 2018 American Association of Neurological Surgeons, announcing a successful clinical introduction of Endexo® Technology to neurosurgical use with the new and exclusive CerebroFlo™ EVD Catheter. “Arkis’ CerebroFlo EVD catheter is a major step forward in next generation clinical technology for neurology and neuro-intensive care. We are excited to have […]
Arkis BioSciences’ new CerebroFlo™ EVD catheter garners promising clinical feedback with its introduction across the U.S. Healthcare market. Read more in the press release.
Med Device Online’s editor Bob Marshall examines the methodology of product development at Arkis BioSciences, and how Arkis is addressing unmet clinical needs.
The Knoxville Business Journal published the following announcement of the grand opening for Arkis BioSciences at the new UT Innovation Campus, adjacent to the Joint Institute for Advanced Materials.
Technovation.biz published coverage today of the progress achieved by Arkis Biosciences.
Arkis BioSciences was proud to announce our Grand Opening this morning at the Cherokee Farm Innovation Campus, a new high-tech facility at the University of Tennessee’s research and development campus, featuring the Joint Institute for Advanced Materials.
Arkis BioSciences is launching the CerebroFlo™ EVD Catheter with Endexo® Technology at the 2017 Congress of Neurological Surgeons, booth 747. Demonstrations are available at the booth for the Single Pass Tunneling Guidewire®, the Subcutaneous Guidewire™, and the CerebroFlo EVD Catheter.
Interface Biologics Inc. (“IBI”), a privately held, commercial stage company developing innovative material science technologies that save lives and improve patient outcomes, is pleased to announce that Arkis BioSciences® has received 510(k) clearance from U.S. Food and Drug Administration (FDA) for its exclusive CerebroFlo™ EVD Catheter with IBI’s Endexo® technology.
Arkis BioSciences, a leading innovator in minimally invasive surgical instrumentation, has obtained FDA clearance of its new external ventricular drainage catheter, CerebroFlo™. The CerebroFlo catheter has demonstrated a 99% reduction in thrombus accumulation in-vitro, and is indicated for temporary use in patients with elevated intracranial pressure, intraventricular hemorrhage, or hydrocephalic shunt infections. Arkis will debut […]
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Arkis BioSciences is ISO 13485:2016 certified for its Medical Device Quality Management System by TUV USA, Inc. (Member of TUV NORD Group).