Hologic, a Nasdaq-listed medical technology company specialising in women’s health, has announced that its Affirm Contrast Biopsy Software has received CE marking, allowing its commercialisation in Europe.
The software, designed to enhance diagnostic capabilities through contrast-enhanced mammography (CEM), received clearance from the US Food and Drug Administration (FDA) in October 2020.
The Affirm Contrast Biopsy Software integrates with Hologic’s Selenia Dimensions and 3Dimensions systems to assist clinicians in targeting and acquiring tissue samples from lesions identified via CEM.
It provides an alternative to MRI-guided biopsies, particularly for cases where tomosynthesis or ultrasound fails to establish a correlation. This approach offers a streamlined biopsy process with reduced examination noise and shorter procedural times compared to MRI.
Hologic international strategic development for breast and skeletal health and gynecological surgical solutions vice president Tanja Brycker said: “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.
“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 maximising workflow efficiencies while helping them to continue to deliver compassionate patient care.”
Hologic’s broader contrast-enhanced mammography and biopsy portfolio includes the Affirm Upright Biopsy System, I-View 2.0 Contrast-Enhanced Mammography Software, and the Affirm Contrast Biopsy Software. Together, these solutions support the clinical pathway from initial screening through to biopsy, helping to optimise diagnostic workflows.
The Affirm Contrast Biopsy Software functions as an optional licence for Selenia Dimensions and 3Dimensions systems. It is designed for use alongside the I-View contrast-enhanced mammography biopsy software and the Affirm breast biopsy guidance system.
The software enables clinicians to localise lesions identified in previous contrast-enhanced mammography exams. During the procedure, following iodine injection, lesions are pinpointed using a scout view and 15-degree image pairs.
In a separate development, Hologic has also announced that the FDA has granted 510(k) clearance for its Aptima SARS-CoV-2 assay. Initially granted emergency use authorisation (EUA) in May 2020, the assay is an in vitro diagnostic test designed to detect SARS-CoV-2 RNA from nasopharyngeal (NP) or nasal swab samples collected from individuals showing symptoms of a respiratory tract infection.
The nasal swab method offers a less invasive alternative to NP swab collection, which requires a healthcare professional to insert the swab deep into the nasal cavity. By contrast, the nasal swab used in the Aptima SARS-CoV-2 assay is inserted only at the nostril entrance, aiming to improve patient comfort while maintaining diagnostic accuracy.
