From 3D to AI and Beyond, How Hologic Continues to Shape the Future of Mammography
Hologic was the first to receive FDA approval for a 3D™ mammography (digital breast tomosynthesis) system in 2011. As the company celebrates 40 years of innovation, our team continues to lead the way in breast cancer detection with AI, advanced imaging, and novel technologies that keep the patient front and center.
In the early 2000s, a small group of creative thinkers, including Hologic co-founder Jay Stein, embarked on a mission to build a 3D mammography system.
“It began as a side project,” said Ken Defreitas, who was part of the team that laid the foundation of what would become Selenia® Dimensions® system, the first FDA-approved 3D™ mammography system. “There were five or six of us in a room often after hours, bouncing around different ideas on how we could do this.”
The concept of tomosynthesis — a medical imaging approach that acquires images by taking multiple X-ray images from different angles — wasn’t new. It had been invented back to the 1930s; however, the use of tomosynthesis in the realm of mammography didn’t start to work its way toward becoming a reality until the 1990s.1 The technology aimed to address the issue of overlapping tissue, especially in dense breasts, which can make it difficult to detect certain lesions.
Over several years and with many iterations and feedback from healthcare providers, the technology being developed by the Hologic team began to take shape. “It was a collaborative effort,” recalled Chris Ruth, who joined the company in 1997. “We had engineers working on the system hardware, software developers fine-tuning the imaging, and clinical experts ensuring the technology met real-world needs. There were also several radiologists who played a major role in giving us feedback and helping to advance the overall project.”
The first prototype, called Genesis, debuted publicly at the annual Radiological Society of North America (RSNA) conference in 2003. Genesis was tucked away in a small section of the Hologic booth, but word spread quickly. “By noon, the area was packed,” Defreitas recalls. “The plexiglass walls were bulging from people leaning on them.”
“It’s been a blessing to work on something that makes such a difference,” said Ken Defreitas, shown here at the European Congress of Radiology (ECR) in 2005. “It’s been worth every minute.”
The success at RSNA was just the beginning. The team refined the technology, leading to the development of the Gemini project, which would eventually become the Selenia Dimensions system. The technology became available in Europe and other countries recognizing the CE mark in 2008 and was approved by the FDA in the U.S. in February 2011.
Bringing more options for radiologists — and clearer images
As adoption of 3D Mammography grew, the need for radiologists to have both 3D and 2D images — especially to compare a woman’s prior mammography exam with the current one to see any changes occurring over time — became clear based on customer and radiologist feedback.
Not long after earning FDA approval for Selenia Dimensions system in 2011, the Hologic team introduced a synthesized 2D image reconstruction algorithm called C-View®, which allowed radiologists to view traditional 2D images reconstructed from 3D scans.
“It eliminates the need to do a combo exam,” explains Ruth, who was also part of the C-View development team. “You don't need to do the tomosynthesis followed by a 2D scan, so it lowers the radiation dose for the patient and it’s a faster scan time.”
Building on the success of its 3D mammography system and C-View software, in 2018 Hologic earned FDA approval for its Hologic Clarity HD® high-resolution imaging to further accelerate screening and analysis. The technology is designed to clearly reveal subtle lesions and fine calcifications to help pinpoint cancers early.
With the arrival of 3D Mammography also came an increase in radiologists’ read time because there were more slides that required review. To solve this problem, the Hologic team introduced a technology called 3DQuorumTM, which is designed to reduce the number of images to review, with no compromise in image quality, sensitivity or accuracy. 2,3 It was the first of many products to come powered by the company’s Genius AI® technology platform.
Discovering boundless potential with AI
The Hologic team continues to harness the power of artificial intelligence (AI), with the goal of making the image review process faster, more efficient and more accurate.
The Genius AI Detection solution draws from a large data set of biopsy-confirmed cancerous lesions to help find even the subtlest signs of breast cancer and flag them for healthcare providers. To spot potentially cancerous regions, the technology looks at each “slice” of the 3D mammography view and analyzes it. The software then assigns a lesion score to each suspicious location. Taking all the scores together, it creates an overall “case score” that reflects the potential that breast cancer is present.
“With imaging volumes growing and widespread staffing shortages, AI can help ease the load for radiologists and give them more confidence while helping to reduce false positives,” said Ashwini Kshirsagar, PhD, Director of R&D, AI, who is part of the team focused on continuously advancing Hologic's AI-powered breast cancer detection technologies.
The next chapter: Advancements in AI, CEM and technology that adapts to patients
Looking ahead, AI is poised to be the next frontier in breast imaging. “AI has the potential to transform cancer detection, just like 3D mammography did,” said Ruth.
Going beyond the ability to detect lesions and flag suspicious areas, the next-generation Genius AI Detection PRO software can help accelerate image review. It analyzes prior exams and uses an intuitive 1-10 scoring scale, while also offering pre-reporting, breast density scoring, patient history and image quality checks. The technology was shown to reduce radiologists’ reading time and perceived fatigue4 — important advancements as workforce shortages worsen globally.
The Hologic team also continues to advance in contrast-enhanced mammography (CEM) with its I-View® 2.0 software, an alternative to MRI for patients who need additional imaging. CEM takes about 8-10 minutes compared with 30-60 minutes5 for an MRI and avoids the need for the patient to spend extended time in one position in a loud gantry.
Another innovation designed with both the patient and provider experience in mind, the new Envision™ Mammography Platform offers a high-speed 3D mammogram that includes tilt positioning that adapts to a woman’s body. Envision is the first FDA-approved mammography focusing technology of its kind and also enhances the detection of subtle objects, minimizes focal spot blur and improves 3D image sharpness.6,7
The Envision platform, developed by a team of passionate engineers and with extensive clinical feedback from healthcare providers, is the only high-resolution 3D mammography system that can tilt to adapt to each patient's body.
As we celebrate 40 years of breakthroughs at Hologic, we honor the visionaries, then and now, who dare to think differently, and the patients whose lives have been touched by their work.
“From the early days of imagining what the first 3D mammography system could look like to today’s AI-powered and next-generation technologies, our teams never stop asking, ‘What’s next?’” said Mark Horvath, President of Breast & Skeletal Health Solutions. “As we look back on decades of innovation, I am proud of how far Hologic has come in advancing breast cancer detection for patients — and excited for what’s ahead.”