FDA Clears Faxitron’s Radiographic Imaging for Core Biopsies & Surgically Excised Specimens

Faxitron, a developer of imaging systems for medicine and life science research, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to VersaVision for radiographic imaging of core biopsies and surgically excised specimens. VersaVision is the company’s newest cabinet x-ray system. It delivers instant imaging and verification of samples with unparalleled imaging resolution, facilitating an improved clinical experience for both providers and patients.
 
The launch of VersaVision signifies a breakthrough in the development of high-resolution imaging technologies, as the system features a proprietary 21 lp/mm detector that enables up to 5X geometric magnification. Faxitron is the only dedicated specimen imaging company that designs and produces its own detectors, which are the key components of radiographic imaging systems, at its factory in Tucson, Arizona. This enables the highest level of imaging quality control. As such, VersaVision is setting a higher standard for quality and clarity in the industry.
 
Moreover, VersaVision ensures an uninterrupted workflow in the clinical setting as radiologists now have the opportunity to access an intuitive system that delivers optimal resolution, faster image acquisition and the ability to image a wide range of specimens. Such improvements in imaging technology not only impact day-to-day operations in radiology, but may subsequently benefit healthcare staff and patients as well. By reducing procedural and verification time, VersaVision may help expedite a more confident diagnosis and a smoother patient experience.
 
“At Faxitron, we are committed to improving the standard of care for breast cancer diagnosis and treatment,” said Donogh O’Driscoll, CFO and COO of Faxitron. “VersaVision is the latest addition to our comprehensive portfolio of imaging solutions that showcases our continued investment in technology and innovation. With a best-in-class high-resolution detector that provides an exceptional 21 lp/mm spatial resolution within a 12”x15” field of view, VersaVision has the potential to reduce the number of patient recalls and re-excision rates—ultimately moving us forward in our mission to help healthcare providers achieve their vision for better care and better patient outcomes.”