Faxitron, based in Tucson, Ariz., has received FDA clearance of its VisionCT, designed to provide easily navigable, true 3D data and rendering of specimens, 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 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,” says 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.”