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CytoSorbents announces FDA has accepted De Novo medical device application
CytoSorbents (CTSO) announced the U.S. Food and Drug Administration, FDA, has accepted its De Novo medical device application for DrugSorb-ATR and initiated substantive review. The goal of ...
Medical Design and Outsourcing8d
A surgical robotics co-founder offers lessons from the de novo pathway
After winning FDA authorization for CMR's Versius, Slack offered advice for navigating the de novo pathway and new ...
FDA Grants De Novo Authorization to OMRON Healthcare for New Blood Pressure Monitors with AI-Powered AFib Detection Feature
In a pivotal stride to address the growing AFib epidemic, OMRON Healthcare today announced the U.S. Food and Drug ...
Business Insider1mon
FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review
The FDA De Novo pathway provides a regulatory process for novel medical devices that are found to be low to moderate risk and lack an appropriate predicate device. Acceptance of the company’s De ...
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FDA grants de novo clearance for NOWDiagnostics OTC syphilis test
NOWDiagnostics has secured de novo clearance from the US Food and Drug Administration (FDA) for First To Know, an at-home syphilis test. With the FDA clearance, the test, which gives users a ...