May 10, 2018

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

 First-ever CT system cleared by the FDA for enhanced intraoperative margin assessment of biopsies and lumpectomies

Tucson, AZ – May 10, 2018Faxitron, a global leader in best-in-class digital specimen imaging systems for breast cancer intervention and life science research, today announced that the U.S. Food and Drug Administration (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.

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,” said Donogh O’Driscoll, CFO and COO 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.”

About Faxitron Bioptics

As a global leader and pioneer for best-in-class digital imaging systems, Faxitron is dedicated to helping healthcare providers and researchers achieve their vision for a better, healthier world at large. Through the continuous innovation and advancement of imaging technologies, Faxitron aims to elevate the standard of care in medicine and the standard of quality in life science research. With applications spanning from breast surgery to pathology imaging, and from preclinical imaging to non-destructive testing, Faxitron is building a comprehensive portfolio of solutions that sets new standards for precision and quality in the industry.

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