Hologic announced its new 2-D/3-D CE-marked Affirm prone biopsy system, revealed at ECR in Vienna, Austria.

The system offers increased automation and significantly improved software with fewer steps than traditional stereotactic biopsies, Ben Boese, product director of biopsy navigation at Hologic, told HCB News. It supports the patient stably while providing isolation from the biopsy needle.

In comparison to existing prone biopsy systems, the new device offers a larger field of view (14.3 cm x 11.7 cm) and a high-resolution (2048 x 1792 pixel) amorphous selenium detector, which captures and converts X-ray energy directly into digital signals.
“A significantly improved imaging capability and a streamlined workflow will provide health care providers with increased confidence for these critical procedures,” said Pete Valenti, Hologic’s division president, breast and skeletal health solutions, in a statement. He also called the Affirm "one of the biggest steps forward in prone biopsy technology since the systems were first introduced over 20 years ago."

Dr. Alejandro Tejerina, breast radiology coordinator at Fundación Terejina in Madrid, has already performed over 30 exams using the new system. He said that the biopsy process is very fast, which is better for their patients and saves money for the diagnostic center. It also provides better access to difficult biopsy areas of the breast.

The system, CE-marked in Europe and pending 510(k) clearance in the United States, expands Hologic's breast biopsy portfolio. Together with the Selenia Dimensions mammography system and Affirm upright biopsy system, the new system can offer radiology facilities all the necessary options for providing minimally invasive breast biopsies to their patients.

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