Hologic has obtained a CE mark in Europe for Affirm, its contrast biopsy software for use in contrast-enhanced mammography (CEM).

Affirm facilitates the targeting and acquisition of tissue samples in lesions identified through prior CEM exams, in cases where a correlate may not have been found using tomosynthesis or ultrasound. The software received US market clearance from the US Food and Drug Administration (FDA) in 2020.

According to Hologic, the software, which is designed for integration with the company’s Selenia Dimensions and 3Dimensions mammography imaging systems, provides patients with a smoother examination experience due to reduced noise and shorter examination time compared with magnetic resonance imaging (MRI). The software is also intended to help maximise workflow efficiencies for radiologists undertaking CEM exams.

With research indicating that the radiologist shortfall in the US could reach almost 42,000 by 2036, in addition to software such as Hologic’s Affirm, other companies are at work on developing generative artificial intelligence (genAI)-based solutions to drive efficiencies in the field and mitigate radiologist burnout.

Tanja Brycker, vice president of international strategic development for breast and skeletal health and gynaecological surgical solutions at Hologic, commented: “We understand the pressures that radiologists work under and the impact that the breast screening and diagnosis process can have on women.

“Our Affirm contrast biopsy solution is designed to support radiologists by maximising workflow efficiencies while helping them to continue to deliver compassionate patient care.”

To expand its women’s health portfolio, Hologic signed a definitive agreement to acquire Gynesonics, a developer of minimally invasive solutions for women’s health, for around $350m in October 2024.

According to GlobalData analysis, the global mammography equipment segment of the broader diagnostic imaging market is growing at a CAGR of 6% and is forecast to reach a value of almost $4bn by 2033, up from around $2.2bn in 2023.