CoreLite Secures TGA Approval: A Milestone in Advancing the Breast Core Biopsy Process in Australia

Cirdan’s advanced X-ray specimen system, CoreLite, receives approval for use in Australian healthcare facilities, marking the second TGA-approved imaging solution introduced by Cirdan in 2025.

Cirdan, a global leader in laboratory information systems and diagnostic solutions, is pleased to announce that its advanced X-ray specimen system, CoreLite, has received approval from the Therapeutic Goods Administration (TGA) for use in Australian healthcare facilities. CoreLite is the second of Cirdan’s range of x-ray specimen cabinets to be awarded approval, following Solas OR, Cirdan’s x-ray system for the operating room, which received TGA approval earlier this year. The approval of CoreLite represents a key advancement in the breast cancer detection and diagnosis pathway, supporting more accurate breast biopsies and equipping radiologists with a highly effective tool to improve diagnostic precision and enhance patient outcomes.

TGA Approval and Cirdan

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority, ensuring that medical devices, medicines, and diagnostic tests meet strict safety, quality, and efficacy standards. Securing TGA approval is a rigorous process that verifies a product’s compliance with national healthcare regulations, confirming its safety and effectiveness for use in Australian healthcare settings.

Cirdan is delighted that two of its x-ray imaging systems, Solas OR and CoreLite, have received approval by the TGA in 2025. This dual approval reflects Cirdan’s commitment to improving diagnostic accuracy and enhancing patient care, whilst reinforcing Cirdan’s growing presence in the Australian healthcare market.

CoreLite: Revolutionising Breast Biopsy

CoreLite is an innovative specimen radiography solution designed to deliver high-resolution imaging in real time during a mammography procedure. Specifically optimised for breast biopsy, the system allows radiologists to image breast core samples directly within or near the biopsy suite, minimising the need for samples to be relayed to a radiography department, and thus saving time during the mammogram procedure. Key features of CoreLite include:

• Rapid, High-Resolution Imaging: CoreLite delivers exceptional imaging to assist radiologists with decision-making.
• Enhanced Workflow Efficiency: A user-friendly interface designed to seamlessly integrate into the biopsy suite, ensuring smooth and efficient procedures.
• Immediate View of Microcalcifications: Optimised for breast biopsy, providing clear, real-time view of microcalcifications to determine the patient’s next steps.

Cirdan’s Comprehensive Pathology Platform

CoreLite is a key component of Cirdan’s broader pathology platform, which offers a fully integrated, end-to-end diagnostic solution. The platform combines Laboratory Information Systems (LIS), digital pathology, and specimen imaging technologies into a unified workflow. This integration allows healthcare professionals to optimise efficiency, improve diagnostic accuracy, and enhance patient outcomes. By seamlessly linking data from imaging and pathology systems, Cirdan’s platform provides a comprehensive solution that improves clinical care and supports informed decision-making.

Supporting the Fight Against Breast Cancer

Breast cancer remains one of the most prevalent cancers globally, and in Australia, it accounts for approximately 28% of all new cancer diagnoses in women. One in seven women will face a breast cancer diagnosis in their lifetime (Breast Cancer Network Australia, 2024).

As part of Cirdan’s commitment to advancing the fight against cancer, the TGA approval of CoreLite is a significant step forward. By enabling a quick and efficient solution for breast biopsy within or close to the biopsy suite, CoreLite will help streamline breast biopsy process. Cirdan is proud to offer this innovative solution to healthcare professionals, helping them deliver the highest standard of care to patients in Australia and beyond.

Looking Ahead

With the successful integration of CoreLite into Australian healthcare facilities, Cirdan is poised to make a lasting impact on breast biopsy and cancer detection. This approval marks just the beginning of the ongoing advancements in diagnostic medicine that Cirdan continues to champion. We look forward to the broader application of our platform and imaging technologies in breast biopsy and other critical areas of medical practice.

About Cirdan

Cirdan is a global leader in laboratory information systems and diagnostic solutions, dedicated to improving healthcare through innovation. With a comprehensive portfolio that includes cutting-edge specimen imaging technology, advanced data analytics, and integrated workflow solutions, Cirdan is committed to helping healthcare professionals improve patient outcomes and streamline clinical workflows.

For more information, please visit: www.cirdan.com

For media enquiries contact: Rebecca Fitton, Marketing Manager, Cirdan.

T: +44 (0) 28 9266 0880 E: rfitton@cirdan.com W: www.cirdan.com