Hologic Gains CE Mark for Affirm Contrast Biopsy Software

Hologic has gained CE mark approval for its Affirm contrast biopsy software, which combines contrast-enhanced diagnostic capabilities with lesion targeting to help streamline workflow and speed biopsy procedures.

The technology, which earned U.S. Food and Drug Administration (FDA) clearance in 2020, was designed to integrate with the company’s Selenia Dimensions and 3Dimensions mammography systems. The contrast biopsy software lets clinicians target and acquire tissue samples in lesions that are spotted through contrast-enhanced mammography (CEM).

The software allows targeting and acquisition of tissue samples in lesions identified on CEM where a correlation may not be found using tomosynthesis or ultrasound. It presents an alternative to MRI-guided biopsy.

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Further, for those who can’t tolerate MRI-guided biopsies, Hologic said contrast-enhanced biopsy offers a smooth examination experience because of less noise and shorter exam time compared to MRI.

“At Hologic, we are committed to helping women live healthier lives everywhere, every day, including through innovative technologies that support the detection and diagnosis of breast cancer,” said Tanja Brycker, VP of international strategic development for Breast & Skeletal Health and Gynecological Surgical Solutions at Hologic. “We understand the pressures that radiologists work under and the impact that the breast screening and diagnosis process can have on women. Our new Affirm Contrast Biopsy solution is designed to support radiologists by maximizing workflow efficiencies while helping them to continue to deliver compassionate patient care.”

Earlier this week, the company announced that it had obtained FDA clearance for its Aptima SARS-CoV-2 assay from nasopharyngeal (NP) or nasal swab samples gathered from people showing signs and symptoms of a respiratory tract infection.