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FDA approves Faxitron’s VisionCT System for true 3D imaging of breast specimens

MDBR Staff Writer Published 11 May 2018

Faxitron has secured approval from the US Food and Drug Administration (FDA) for its VisionCT system for true imaging of breast specimens.

The VisionCT is claimed to be the only FDA-approved clinical CT system that can deliver true 3D specimen radiography.

It will help clinician to automatically take images around the entire specimen and reconstruct navigable 3D render in real time, helping in detailed margin assessment.

The system can rebuild the specimen in up to 1024 slices at a standard slice thickness of 100μ, enabling complete and detailed radiographic assessment of margin status, as well as reduce patient recall and re-excision rates.

Faxitron’s system images around less than 60 degrees of the specimen rather than the entire 360 degrees.

The scope of tomosynthesis reconstruction is limited in high resolution margin assessment, as fewer slices will be constructed compared against CT.

Faxitron has developed VisionCT based on its expertise in planar (2D) and orthogonal specimen radiography.

The system holds capacity to offer easily navigable and true 3D data, in addition to rendering specimen and immediate traditional orthogonal images.

At present, planar specimen radiography is the standard of care in intraoperative margin assessment.

Faxitron collects at least a single additional planar view of the specimen, taken orthogonally, to support better margin assessment and ensure all suspect or diseased tissue is excised.

Faxitron CFO and COO Donogh O’Driscoll said: “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.

“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.”

Image: Faxitron’s VisionCT system will deliver true 3D specimen radiography. Photo: courtesy of axitron Bioptics, LLC.