Faxitron VisionCT System Granted 510(k) Clearance for True 3D Imaging of Breast Specimens

Faxitron, a global leader in best-in-class digital specimen imaging systems for breast cancer intervention and life science research, has received U.S. Food and Drug Administration (FDA) clearance to VisionCT, the first and only FDA-approved clinical CT system dedicated to delivering true 3D specimen radiography.
 
VisionCT is the evolution of Faxitron’s efforts and market leadership in planar (2D) and orthogonal specimen radiography. It is designed to provide easily navigable, true 3D data and rendering of the specimen, in addition to immediate traditional orthogonal images. As a result, it enables enhanced margin assessment and drives the potential for improved surgical outcomes.
 
Currently, planar specimen radiography is the standard of care in intraoperative margin assessment. Faxitron champions the collection of at least a single additional planar view of the specimen, taken orthogonally, to provide for more thorough margin assessment in an effort to ensure all suspect or diseased tissue is excised. This requires the surgeon and radiologist to attempt to visualize the microcalcifications or lesion in three-dimensional space by viewing the two images individually, but in relation to one another. The challenge is that both collecting and visualizing the images are manual processes, and therefore may not always be standard practice.
 
The Faxitron VisionCT was designed to fully enhance the clinician’s ability for detailed margin assessment by automatically taking images around the entire specimen and then reconstructing a navigable 3D render in real time. The system reconstructs the specimen in up to 1024 slices at a standard slice thickness of 100 micron, allowing for the most complete and detailed radiographic assessment of margin status, which offers the best potential to reduce patient recall and re-excision rates. Although tomosynthesis has been offered as a competing technique, it images around less than 60 degrees of the specimen rather than the entire 360 degrees. Therefore, tomosynthesis reconstruction of a specimen is of limited use for high resolution margin assessment due to significantly fewer slices being reconstructed as compared to computed tomography (CT).
 
“As imaging innovations in breast screening continue to drive earlier detection of abnormalities in breast tissue, there is a parallel need for ongoing improvements in methods for assessing and confirming specimen margin status during surgery,” said Donogh O’Driscoll, chief financial officer and chief operating officer of Faxitron. “VisionCT gives providers a clearer, more detailed view of breast specimen margin status than ever before. We’ve spent decades pioneering new technologies that contribute to a higher standard of care for patients and are proud that legacy continues as we introduce VisionCT to the market.”
 
VisionCT is a fully automated cabinet X-ray system that is the only FDA-approved clinical specimen CT dedicated to delivering true 3D specimen radiography. The system is equipped with a motorized, 360-degree rotating platform and can capture up to six high-resolution images per second. Automated magnification allows for optimal resolution for any specimen size up to 11cm in diameter. The system requires no manual specimen repositioning. Users can review orthogonal images while the specimen is being scanned and reconstructed in real time. Automatic metal artifact correction minimizes interference from metal clips and markers.
 
Faxitron is a global developer of best-in-class digital imaging systems. With applications spanning from breast surgery to pathology imaging, and from biological irradiation and preclinical imaging to non-destructive testing, Faxitron is building a portfolio of solutions that sets new standards for precision and quality in the industry.