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“The CE mark allows us to support many more clinical labs and organizations globally, including those performing COVID-19 testing during the current pandemic,” the company said. Read More
If an order is finalized, manufacturers that intend to market this type of device would need to apply for a 510(k) clearance prior to marketing it. Read More
The bronchoscopes offer large instrument channels and have been re-designed for easier device insertion and strong suction capability, the company said. Read More
The system's simplicity enables surgical application “using minimal, straightforward steps which address challenges of current standard plate and Nitinol staple options,” the company said. Read More