CapeRay Medical's PantoScanner combines ultrasound with slot-scanning digital mammography to bring the best of both modalities to breast screening, according to Kit Vaughan, CEO of the company. CapeRay has secured venture capital funding and small business R&D support from the South African government with hopes to begin clinical trials of the system later this year.
PantoScanner uses a slot-scanning mammography tube that scans across the breast, with x-ray photons collected with charge-coupled device (CCD) digital technology. An automated ultrasound component integrated with the system provides the modality's unique capabilities in breast cancer detection, such as in women with dense breast tissue, as well as better localization of suspicious masses.
CapeRay finished a preproduction prototype of the system, and plans to begin clinical trials of the unit in July, Vaughan said. One system will be installed at a government-operated facility and the other at a private clinic. Both units will collect data comparing the system's performance with analog mammography.
CapeRay will use the data to support a CE Mark submission to the European Union and a 510(k) application with the U.S. Food and Drug Administration; however, the company is focusing on Europe first as its primary market, Vaughan said. The initial version of PantoScanner will only perform mammography, with availability in January 2012, while the ultrasound component will be added later. The company expects a dual-modality PantoScanner to be available in May 2012.