FDA approval for VisionCT, the first and only FDA-approved clinical CT system dedicated to delivering true 3D specimen radiography.- Faxitron Bioptics LLC.

Faxitron Bioptics LLC, a global leader in best-in-class digital specimen imaging systems for breast cancer intervention and life science research, announced that the FDA has granted 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 pioneering 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.

Comment: 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..