Praxis Medical Announces FDA Clearance of the CytoCore Soft Tissue Biopsy Device
Tampa, FL - March 31, 2020 - Praxis Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the CytoCore fine needle soft tissue biopsy device.
Fine needle biopsy is a procedure in which a needle is advanced into a suspicious mass under imaging guidance and cellular material is removed for microscopic analysis. If the sample is adequate, this material is used to determine if a mass is malignant and identify tumor-specific mutations to guide personalized treatment.
The CytoCore is a device for performing fine needle soft tissue biopsy. The device has an internal motor that rotates the needle during biopsy to facilitate cellular harvesting. Its unique scissor-slide mechanism allows the physician to draw back suction and activate the motor with just one hand. It is compatible with any FDA-cleared 22-25 gauge soft tissue biopsy needle.
"The CytoCore will be a significant addition to my practice because I am confident my biopsies will now yield consistent cellular material each time resulting in fewer passes and shorter procedures. This technology lends itself particularly well in the biopsy of thyroid nodules, which have up to a 30% inconclusive rate that leads to unnecessary surgeries," said John Fisher, M.D., an Interventional Radiologist in Clearwater, FL, the CEO of Praxis, and the inventor of the CytoCore. "This new technology promises to dramatically improve the soft tissue biopsy procedure by increasing diagnostic accuracy that results in better clinical outcomes for my patients.”
"Praxis develops and commercializes state-of-the-art technologies that enhance patient experience, increase clinician productivity, and drive better health outcomes” said Nat Pariseau, COO of Praxis. “The CytoCore was designed to collect robust cellular samples more quickly, comfortably, and effectively than alternative methods. We are expanding this technology into other applications for release in the near future.”
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.