Breast cancer detection can be challenging with standard digital mammography, particularly in women with dense breast tissue where abnormalities may be more difficult to identify. Addressing this challenge, CapeRay developed its innovative Aceso system, a dual-modality imaging platform that combines full-field digital mammography with automated breast ultrasound to provide clinicians with more comprehensive diagnostic information. By integrating complementary imaging technologies into a single solution, Aceso is designed to enhance breast imaging capabilities, support earlier detection, and improve clinical decision-making.

A Legacy of Imaging Innovation

CapeRay’s journey is built on decades of scientific advancement in medical imaging, tracing its roots to research that helped shape the evolution of X-ray technology and computed tomography. In the late 1950s, Allan MacLeod Cormack’s pioneering work on measuring X-ray attenuation through the human body contributed to the development of computer-assisted tomography, earning him the Nobel Prize in Medicine in 1979 alongside Godfrey Hounsfield.

The company’s technology foundation also extends to the development of low-dose X-ray imaging by De Beers in the 1990s. Originally developed for diamond security applications, the technology demonstrated potential for broader imaging uses. In 1999, the University of Cape Town and De Beers established African Medical Imaging (AMI) to advance the technology for medical diagnostics.

Following years of research and development, AMI evolved into CapeRay Medical in 2010, focusing on transforming breast imaging through advanced digital technologies. The company began developing a dual-modality imaging approach that combined low-dose digital X-ray with automated breast ultrasound to provide clinicians with a more complete view of breast tissue.

CapeRay continued advancing its technology through clinical validation, intellectual property development, and regulatory achievements. The company’s Aceso system demonstrated the potential of combining complementary imaging modalities to identify findings that may be difficult to detect through conventional mammography alone, particularly in women with dense breast tissue.

In 2017, CapeRay achieved a significant milestone with CE Mark approval for Aceso, strengthening its position in the global medical imaging landscape. Through a foundation built on scientific research, engineering expertise, and clinical collaboration, CapeRay continues to advance solutions designed to improve breast imaging and patient care.

Technology and Engineering

Behind CapeRay’s Aceso system is a multidisciplinary engineering approach that integrates industrial design, mechanical engineering, electronics, and software development. The company’s team works across multiple disciplines to ensure that every component functions as part of a unified imaging platform.

The industrial design process focuses on creating a system that balances performance, usability, and patient experience through careful consideration of ergonomics, materials, aesthetics, and human-machine interaction. Mechanical engineering supports the development of the system’s structural components and imaging mechanisms, while electronic engineering enables precise communication and control across the platform.

Complementing the hardware is a software architecture designed to manage imaging acquisition and coordinate the system’s dual-modality capabilities. By bringing together advanced engineering disciplines, CapeRay has created an imaging platform designed to combine functionality, efficiency, and ease of use for healthcare professionals.

Advancing Breast Cancer Detection Through Dual-Modality Imaging

Mammography has remained the standard approach for breast cancer screening for decades, but its ability to detect early-stage cancers can be limited in women with dense breast tissue. CapeRay’s Aceso platform addresses this challenge by integrating full-field digital mammography (FFDM) and automated breast ultrasound (ABUS) into a single imaging system.

By combining two complementary imaging technologies, Aceso is designed to provide clinicians with a more comprehensive assessment of breast tissue while improving correlation between mammography and ultrasound images. The system enables both imaging modalities to capture the breast in the same position and compression state, supporting more efficient image review and diagnostic evaluation.

Clinical evaluations of the technology demonstrated the potential of dual-modality imaging to identify findings that may not be visible through mammography alone, particularly in dense breast tissue. Beyond diagnostic capabilities, Aceso is designed to improve workflow efficiency by reducing the need for separate imaging systems and creating a more streamlined experience for patients and healthcare providers.

Through its integrated approach to breast imaging, CapeRay is advancing diagnostic technology with the goal of supporting earlier detection, improving clinical confidence, and enhancing patient outcomes.

Quality and Regulatory Commitment

CapeRay places strong emphasis on quality management throughout the development and delivery of its medical imaging solutions. The company has established a Quality Management System designed to identify, control, and monitor processes that influence product quality while ensuring compliance with applicable standards and regulatory requirements.

CapeRay’s quality framework is certified in compliance with ISO 13485:2016, the internationally recognized standard for quality management systems in the medical device industry. The system is built around principles including customer focus, leadership, employee involvement, process management, continual improvement, data-driven decision-making, and strong supplier relationships.

Through this structured approach, CapeRay aims to maintain high standards of safety, reliability, and performance across its medical imaging technologies while supporting continuous improvement throughout the product lifecycle.

KIT VAUGHAN | CEO

Kit Vaughan’s experience over the past four decades includes a post-doctoral fellowship in orthopaedic engineering at Oxford University, a tenured professorship at the University of Virginia, and 14 years as the Hyman Goldberg Chair in Biomedical Engineering at the University of Cape Town (UCT). During this latter period, he helped to pioneer the medical device industry in South Africa, contributing to Disa Vascular, Acorn Technologies, Lodox Systems, and Strait Access Technologies. Kit is a Fellow of the International Academy for Medical and Biological Engineering, and his qualifications include a BSc (Honours) in applied mathematics and physics (Rhodes), a PhD in musculoskeletal biomechanics (Iowa) and a DSc (Med) in biomedical engineering (UCT). He is the holder of multiple United States patents in the field of biomedical engineering.