It was exactly two years ago that we launched our new company, CapeRay. Earlier this week, over 70 guests joined the CEO Kit Vaughan and his staff at their expanded facilities for an opportunity to celebrate the company’s recent accomplishments. These included a national innovation award in June, plus the ISO certifications and CE Mark for Pandia in July. The highlight of the evening was the launch of CapeRay’s new full-field digital mammography (FFDM) system, the PantoScanner Soteria.
Our breast imaging products have been built on a platform known as the PantoScanner where the prefix “panto-” comes from Greek and means “all”. The PantoScanner will be produced and sold in three variations with the first being an entry-level system, known as Soteria — the Greek goddess of deliverance from harm — which is an FFDM device based on our Pandia digital X-ray camera. This was the evening for Soteria’s moment in the spotlight (see photo at right).
Michael Evans, CapeRay’s chief technical officer (CTO), spoke at the launch: “I would like to recognize the creative contributions which have helped us get here. Our guiding design philosophy has strictly been ‘Less is More’ and asking ourselves, ‘What can we do without?’ and ‘How can we make it simpler and easier to use?’ I am proud to say this has resulted in a robust and elegant product that required an extraordinary combination of multiple disciplines, including mechanical, materials, electrical, electronic and software engineering, industrial design and radiology.”
Michael and his team tested Soteria extensively on a range of phantoms and it has proven up to the task of identifying very small structures — indicative of micro-calcifications associated with breast cancer — as well as structures whose density is very similar to the surrounding tissue. At left is an image of a surgically excised specimen of breast cancer, showing the detailed tissue structures, including calcifications. Soteria produces images that are equivalent in quality to other FFDM systems on the market but at a lower mean glandular dose (just 1.3 mGy for a breast thickness of 4.5 cm compared with an acceptable level of 2 mGy).
Soteria’s ultimate test will be on patients. With a simple user interface for the radiographer — the ubiquitous iPad — we will conduct a clinical evaluation at Groote Schuur Hospital, beginning in early September. These data will form the basis for a CE Mark and FDA approval, an exciting next step on our journey.