Praxis Medical announced that it received CE mark approval for its CytoCore soft tissue biopsy device.
Tampa, Fla.-based Praxis said in a March 8 news release that the approval for CytoCore allows the country to expand its technology into European Union member countries and offer fine-needle biopsies on a global scale.
CytoCore is designed to rotate a fine needle during biopsy to increase cell yield per pass. The device consists of a 5 ml syringe with adjustable suction, a Luer adaptor compatible with various needle gauges and lengths and an ergonomic slide switch for drawing back the syringe and initiating the motor in a single stroke.
The platform received FDA 510(k) clearance on March 31, 2020, and has held ISO 13485:2016 certification since November 12, 2020.
“For a company of our age and scale to achieve these certifications in just over one year is an accomplishment of which we are very proud,” Praxis COO Nat Pariseau said in the release. “Our team worked tirelessly to develop and maintain an efficient system that enhances our commitment to design control, risk management, vendor evaluation & oversight, customer satisfaction and patient safety.”