Praxis Medical announced on March 8, 2021, that it received CE Mark approval for the CytoCore®, a soft tissue biopsy device designed to harvest better samples in fewer passes with the smallest needles. This approval allows Praxis Medical to expand its innovative technology into European Union member countries and improve fine needle biopsies on a global scale.
Praxis Medical also received ISO 13485:2016 certification on November 12, 2020. ISO 13485:2016 is the medical device industry’s most widely used standard for quality management systems (QMS). Adopting ISO 13485 demonstrates a commitment to the safety of medical devices and provides a practical foundation for complying with country-specific regulations around the world.
“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,” says COO Nat Pariseau. “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.”
Praxis received FDA 510(k) clearance for the CytoCore® March 31, 2020.
About Praxis Medical
Praxis Medical is a medical device company headquartered in Tampa, FL. Praxis was founded by John Fisher MD, a practicing Interventional Radiologist who spent the last 20 years inventing and co-inventing minimally invasive medical devices. Praxis is committed to developing innovative technology that addresses unmet clinical needs to improve the lives of doctors, providers, and – most importantly – patients around the globe.
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