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Mammo Density Impact, News from JPM26, and Bayer’s Molecular Move
January 15, 2026
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Together with
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“The math is simple: chest X-rays make up nearly 15 to 25% of all imaging volume worldwide. In an era of global radiologist shortages we are spending a massive portion of our professional lives confirming the absence of disease. It’s time for a paradigm shift.”
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Cardiothoracic radiologist Firdaus Mohamed Hoesein, MD, PhD, making the case for autonomous reading of routine chest X-rays.
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Breast density has a well-known effect on the accuracy of mammography screening – and it’s not a positive one. But a new study in Academic Radiology sheds light on density’s impact thanks to a massive patient population and its use of digital breast tomosynthesis, the most current breast screening technology.
Breast density is known to reduce the effectiveness of X-ray mammography by obscuring suspicious areas and making cancers harder to find.
- Women with dense breast tissue are typically directed to other imaging modalities for screening, such as ultrasound, breast MRI, and contrast-enhanced mammography.
The problem posed by breast density is significant enough that in 2024 the FDA implemented new MQSA rules requiring women getting screening mammograms to be notified of their density status.
- It’s particularly important because having dense breast tissue is also a risk factor for breast cancer.
In the new study, MGH researchers aimed to quantify exactly how much breast density affects mammography screening through a large patient population screened with DBT, the state of the art in the U.S.
- Researchers included 111.1k women who got DBT exams from 2013 to 2019 at their institution.
They then calculated important metrics like sensitivity and specificity, as well as cancer detection and false-negative rates, across the four categories of dense breast tissue, from entirely fatty (A) to extremely dense (D), finding…
- Sensitivity was lowest in extremely dense tissue compared to entirely fatty (62% vs. 93%).
- Specificity was also lower for extremely dense and heterogeneously dense categories compared to entirely fatty (93% for both vs. 97%).
- The false-negative rate for extremely dense tissue was over 8X that of entirely fatty based on adjusted odds ratio (aOR = 8.35).
- While the abnormal interpretation rate was 57% higher for extremely dense versus entirely fatty tissue.
The Takeaway
The new findings are some of the most definitive yet on the negative effect breast density has on screening mammography’s accuracy and support the FDA’s 2024 notification requirement. They hopefully will spur development of new technologies to mitigate density’s impact.
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AI Echo Detection of Cardiac Amyloidosis
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Elevating Breast Cancer Detection
Breast Suite from DeepHealth is a new package of AI-powered solutions delivering increased breast cancer detection rates, risk stratification tools, and viewing and reporting workflow acceleration. Find out how it can benefit your practice today.
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- CEM for Dense Breast Surveillance: Contrast-enhanced mammography could be a useful tool for surveillance of breast cancer survivors with dense breast tissue. In a study in Clinical Breast Cancer of 176 women with dense breasts and personal histories of breast cancer, CEM had a cancer detection rate of 34 per 1k exams, sensitivity of 100%, and specificity of 73%. Also, 38% of the CEM-detected cancers only showed up on images with functional data from contrast. CEM could be used instead of breast MRI in this patient population.
- Racial Differences in Breast Tissue: Higher background parenchymal enhancement on breast MRI scans can indicate elevated breast cancer risk, and a new study in Radiology found Black women were more likely to have high BPE than White women. Among 2.5k patients, Black women had 31% higher odds of high BPE levels after adjusting for higher breast density rates among White women. High BPE is a marker of breast cancer risk that could help clinicians target interventions toward Black women, who have higher breast cancer mortality rates.
- Mobile Mammography’s Challenges: A new study in Academic Radiology highlights both the challenges and opportunities of mobile mammography versus hospital-based breast screening. Researchers found that among 333 women, mobile mammography was better at reaching patients who identified as non-Hispanic Black (68% vs. 40%), were uninsured (71% vs. 2.1%), and had no primary care provider (35% vs. 9.8%). But mobile mammography’s time to diagnostic resolution was longer (28 vs. 11 days), and patients were less likely to return for diagnostic follow-up imaging (18% vs. 3.8%).
- Bayer’s Molecular Imaging Move: Pharmaceutical giant Bayer is adding molecular imaging to its radiology contrast media business by acquiring radiotracers under development for cardiac amyloidosis imaging by specialty pharmaceutical company Attralus. Attralus develops diagnostic and therapeutic agents for cardiac amyloidosis, and Bayer is acquiring its AT-01 PET tracer (phase III) and AT-05 SPECT tracer (phase I). AT-01 is a pan-amyloid PET agent with both orphan and breakthrough designations, while AT-05 is a technetium-based SPECT agent. Attralus will retain its AT-02 amyloid removal therapeutic agent.
- Google Updates MedGemma Open AI: At this week’s J.P. Morgan Healthcare Conference, Google announced it has updated its MedGemma open generative AI model to support 3D images, including CT and MRI. Google launched the model in June 2025 as a free tool for development of more specific AI algorithms for research and commercial use. MedGemma 1.5 4B includes other enhancements like support for longitudinal review of X-ray images and anatomical localization. Google also released MedASR, an automated speech recognition model for medical dictation.
- Wearable Breast Ultrasound Launches: Another new technology launching at this week’s J.P. Morgan Healthcare Conference is ATUSA, a wearable 3D quantitative breast ultrasound system developed by iSono Health. ATUSA was cleared by the FDA in 2022 as a tool for making high-quality ultrasound available more broadly, such as at local clinics. iSono Health also announced the opening of a new Series A funding round ($14.7M raised to date) and the start of the AUDIBLE pivotal study to compare ATUSA to conventional mammography and breast MRI.
- Polarean’s Xenon MRI Revelations: Polarean’s xenon gas MRI technology showed which children with cystic fibrosis were likely to have worsening lung function in a new study in CHEST. Kids with abnormal xenon MRI metrics – specifically ventilation defect percent – were 3X more likely to have worsening lung function compared to those with normal VDP. The findings could lead to earlier detection of lung deficits. Separately, Polarean went private in December, with about 35% of the company now owned by contrast company Bracco and stable isotope developer NUKEM Isotopes.
- FDA Shelves Global Software Guidance: The FDA quietly shelved 2017 guidelines on regulating medical software that harmonized U.S. regulatory policy with the rest of the world. The guidance was for vendors and FDA staff and tried to align U.S. regulations with those of countries in the International Medical Device Regulators Forum, an international group that promotes regulation harmonization. The FDA’s move could be a sign that the agency plans to adopt medical software regulation policies – such as for AI – that diverge from the rest of the world.
- ScreenPoint Partners with Ferrum: ScreenPoint Medical is making its Transpara Breast AI Suite available on Ferrum Health’s Model Hub AI orchestration platform through a new partnership between the companies. The suite includes algorithms for breast cancer detection, density analysis, and temporal comparison of mammograms. Separately, a recent clinical study in Cancers used Transpara to triage biopsies for 202 women with suspicious DBT mammograms, finding high sensitivity and a negative predictive value of 95% while classifying 51% of cases as high risk.
- Vista AI Nabs $29.5M in Series B: Automated MRI software company Vista AI closed a Series B funding round that raised $29.5M. Vista will use the funds to expand from its core focus on cardiac MRI into other clinical applications, such as brain, prostate, and spine imaging. The company’s ultimate goal is to offer a broad platform for automated MRI scanning that can assist MRI technologists and reduce scan variability and complexity. Vista is also expanding into remote scanning for cardiac MRI.
- deepc Connects with Konica Minolta: AI platform company deepc signed an agreement to make its deepcOS marketplace available on Konica Minolta Healthcare Americas’ Exa Platform, including PACS/RIS, enterprise, and teleradiology implementations. The partnership will give Konica Minolta customers access to AI algorithms available on deepcOS.
- Big Gains in Cancer Survival: The number of Americans surviving a cancer diagnosis has hit a historic threshold. A new American Cancer Society report found that the survival rate for all cancers hit 70% for people diagnosed from 2015-2021. Cancer mortality has dropped by 34% from its peak in 1991, averting 4.8M deaths. Lung cancer will continue to cause the most cancer deaths in 2026, but five-year survival for advanced lung cancer has increased for both regional-stage disease (from 20% to 37%) and distant-stage disease (from 2% to 10%).
- LLMs Reshape Academic Publishing: A new research study in Science shows how large language models are reshaping academic publishing. Researchers scoured preprint publications and peer-reviewed studies to find that LLM adoption boosts a researcher’s scientific output by 24-89%, with especially large increases for authors with higher writing and language barriers. LLM users read and cited more diverse literature, but there was also a trend toward more sophisticated language being used in weaker manuscripts.
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A Next-Generation Oncology Ecosystem
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Bring Your Radiology AI into Your Clinical Workflows
CARPL enables healthcare providers and researchers to develop, test, and deploy their own AI models within existing clinical infrastructure. From seamless data ingestion and de-identification to model training, packaging, and live deployment, CARPL provides an end-to-end environment tailored for radiology.
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Transform Your Workflow with Intelligent Imaging
Radiology departments face growing challenges: higher workloads, fewer staff, and tighter budgets. Discover how intelligent imaging technology from Siemens Healthineers streamlines processes, reduces stress, and improves outcomes. Access the white paper now and transform your workflow.
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