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AI Boosts DBT, FDA Turns to AI, $15M for CTE Study
May 12, 2025
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Together with
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“This is more lip service to avoid criticism from stripping the agency of the staff needed to do the work. The value of FDA reviewers’ experience is well beyond current AI capabilities.”
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Regulatory consultant Sharon Hertz, on the FDA’s proposal to use AI for scientific review.
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Did you miss our webinar last week on Top Productivity Tips for Radiologists? Don’t despair – it’s available on demand! Check it out now to learn how radiology professionals at the University of Michigan Health – Sparrow are using new imaging IT tools to manage rising imaging volumes.
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A real-world study of AI for DBT screening found that AI-assisted mammogram interpretation nearly doubled the breast cancer detection rate. Radiologists using iCAD’s ProFound AI software saw sharp improvements across multiple metrics.
Mammography screening has quickly become one of the most promising use cases for AI.
- Multiple large-scale studies published in 2024 and 2025 have documented improved radiologist performance when using AI for mammogram interpretation, with the largest studies performed in Europe.
Another new technology changing mammography screening is digital breast tomosynthesis, which is being rapidly adopted in the U.S.
- DBT use in Europe is occurring more slowly, so questions have arisen about whether AI’s benefits for 2D mammography would also be found with 3D systems.
To investigate this question, researchers writing in Clinical Breast Cancer tested radiologist performance for DBT screening before and after implementation of iCAD’s ProFound V2.1 AI algorithm in 2020 at Indiana University.
- Interestingly, the pre-AI period included use of iCAD’s older PowerLook CAD software.
Across the 16.7k DBT cases studied, those with AI saw …
- A sharp improvement in cancer detection rate per 1k exams (6.1 vs. 3.7).
- A decline in the abnormal interpretation rate (6.5% vs. 8.2%).
- Higher PPV1 (rate that abnormal mammograms would be positive) (8.8% vs. 4.2%).
- Higher PPV3 (rate that biopsies would be positive) (57% vs. 32%).
- Higher specificity (94% vs. 92%).
- No statistically significant change in sensitivity.
The findings on sensitivity are curious given AI’s positive impact on other interpretation metrics.
- Researchers postulated that there was higher breast cancer incidence in the post-AI implementation period, which could have been caused by AI finding cancers that were missed in the period without AI.
The Takeaway
The radiology world has seen multiple positive studies on AI for mammography, but most of these have come from Europe and involved 2D mammography not DBT. The new results suggest that AI’s benefits will also transfer to DBT, the technology that’s becoming the standard of care for breast screening in the U.S.
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Unprecedented Insights Made Possible with AI
With the largest normative dataset of whole-body imaging in the world, Prenuvo’s AI researchers partner with the best academic minds to understand – like never before – what “normal” aging means. Learn about their work today.
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Meet Merge at SIIM 2025
Merge puts your workspaces, clinicians, and imaging transformation into focus. Explore their market-leading solutions at SIIM 2025 at booth #632, or schedule your visit today.
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Visit Kailo Medical at SIIM 2025
Learn about the latest synoptic reporting solutions by visiting Kailo Medical at booth #539 at SIIM 2025. Book an appointment today to find out how their technology can make radiology reporting easier while maximizing efficiency.
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- FDA Turns to AI for Product Review: The FDA has found a novel solution to the shortage of reviewers for medical product applications: Put generative AI to work. The agency this week said it completed a successful pilot test of AI-assisted scientific review, and plans an “aggressive” rollout of AI across all its centers using a secure, unified platform. Generative AI will be used to free up scientific reviewers from “non-productive busywork” and spend less time on “tedious, repetitive tasks” that slow down the review process.
- Centralized CT Lung Cancer Screening: What’s the best way to boost compliance with CT lung cancer screening? A new meta-analysis in CHEST found higher patient adherence rates in centralized screening programs that used specialized care teams to handle shared decision-making, scheduling, and follow-up care. In a review of 12 studies covering 17.2k patients, centralized programs had higher adherence rates than decentralized ones (69% vs. 37%), and participants had a 3X higher odds ratio of getting screening (OR=3.3).
- Cancer Incidence Rises in Younger People: Even as cancer mortality falls, there’s been a disturbing rise in incidence of some cancers in younger people. A new NIH report documents the trend, finding that out of 33 cancers studied, incidence rose for 14 cancers in people younger than 49. The good news is that death rates in younger people did not increase for most of these cancers, except for colorectal and uterine cancers. Also, cancer incidence declined in younger people for 19 cancers, including lung and prostate cancers.
- Ultrafast Breast MRI Protocol Falls Short: In a setback for accelerated breast MRI, researchers in Radiology found that an ultrafast breast MRI protocol didn’t measure up to a full 2D dynamic contrast-enhanced breast MRI exam. In a small study of 31 women with 59 lesions, ultrafast breast MRI scored 15% lower than DCE-MRI for lesion conspicuity (3.5 vs. 4.1) and 44% lower for image quality (2.3 vs. 4.1). The study casts doubts about ultrafast breast MRI’s efficacy for wider breast screening.
- CT Skeletal Muscle Metrics: CT metrics of body composition like skeletal muscle mass are showing potential for opportunistic screening of conditions like sarcopenia. A new meta-analysis in AJR helps move the field along by setting reference values derived from 14 research studies of 17k healthy young adults. The global mean value for skeletal muscle index was 55 in men and 42 in women, while for skeletal muscle density it was 47 Hounsfield units in men and 44 HU in women.
- Coreline Inks AI Partnerships: South Korean AI company Coreline Soft signed a pair of partnerships. First, the company renewed its relationship with 3DR Labs to supply its AVIEW CAC coronary artery calcium scoring software. The agreement includes the latest FDA-cleared version of AVIEW CAC. Second, Coreline cemented a relationship with Bayer to supply its AI algorithms – including AVIEW LCS for lung cancer screening – through the company’s Calantic AI platform. Coreline sees the European market and particularly Germany as a focus for the relationship.
- Tracking Long COVID’s Lung Changes: PET/MRI and dual-energy CT can be used to track long COVID’s impact on the lungs. In a new study in JNM, researchers scanned 98 patients 300 days after infection with COVID-19. PET/MRI found abnormalities in 57% of patients, with 24% showing cardiac involvement suggestive of myocarditis and 22% of pericarditis. DECT found abnormalities in 90%, with 67% showing pulmonary infiltrates and 59% abnormal heart perfusion. A subgroup of patients also had annular and vascular inflammation.
- Sun Nuclear Buys Oncospace: Nuclear medicine software company Sun Nuclear acquired Oncospace, a developer of cloud-based AI solutions for radiation oncology. Oncospace was founded in 2018 and has two main software offerings: The first is Gateway, for converting archived Philips Pinnacle treatment plans to modern planning solutions like Raysearch Raystation and Varian Eclipse. The second is a predictive treatment planning solution for analyzing thousands of treatment plans to develop best-practice dosimetry goals. Sun Nuclear is a subsidiary of Mirion Medical.
- BrightHeart’s Latest FDA Clearance: BrightHeart received FDA 510(k) clearance for updates to its BrightHeart platform that add the capability for clinicians to access the BrightHeart ultrasound analysis software in real-time through a cart-side tablet. BrightHeart’s AI software specifically screens for congenital heart defects and will now be easier to use following the FDA clearance of its tablet interface. The company is preparing for a limited market release to deploy the platform in an exclusive set of clinics.
- Cleerly + Cardiac Care Alliance: Cleerly announced a new partnership to make its AI-powered coronary artery assessment technology available through Cardiac Care Alliance’s cardiovascular care network. As part of the partnership, CCA’s offering to payors and practices will now include Cleerly’s CCTA AI technology to ensure symptomatic patients can undergo noninvasive assessment prior to cardiac catheterization procedures. The initiative will launch with cardiology practices in Texas, with plans for broader implementation.
- CaliberMRI Extends MRI QA Software: MRI quality assurance software developer CaliberMRI has expanded the number of scanners compatible with its qCal-MR software platform. The application can now perform phantom scan analysis on over 40 MRI scanner models, ranging from 0.064T to 7T machines. CaliberMRI’s software is used to calibrate MRI scanners to improve the reproducibility of quantitative MRI scans for applications like clinical trials research.
- Massive $15M Grant Funds CTE Research: NIH issued a massive $15.3M grant to a consortium of academic centers to study chronic traumatic encephalopathy. Boston University will lead the project, called DIAGNOSE CTE Research Project-II, in examining how biomarkers like tau PET, multimodality imaging, and blood tests could help clinicians develop tools for diagnosing CTE in living people, as currently the only definitive diagnosis is via autopsy. Researchers plan to recruit 350 men 50 years and older, including 225 former college and pro football players.
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See AGFA Innovations at SIIM 2025
Visit AGFA HealthCare at SIIM 2025 to see how their innovative approach to enterprise imaging is advancing diagnostic confidence, clinical collaboration, and operational efficiency across healthcare systems. Book a demo today or swing by booth #431-433.
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Visit United Imaging at ISMRM 2025
United Imaging is reaching new clinical heights in MRI with new innovations like 5T MRI and its uAiFI technology. Visit the company at ISMRM 2025 at booth #A18 or attend one of its conference events.
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Achieve More with AI You Can Trust
Visit Microsoft at SIIM 2025 to experience how Microsoft Cloud for Healthcare can empower your workforce and unlock insights. Request a meeting or stop by at booth #314-316.
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- Say Goodbye to On-Premises Costs: Free up resources with cloud-based solutions from Optum for medical imaging. Visit this page to see how you can say goodbye to on-premises costs!
- 60% of Imaging Is Not Followed-Up On: Missed follow-ups lead to delayed diagnoses, gaps in care, and real liability for providers. PocketHealth helps you seamlessly manage follow-ups through automated notifications, AI-powered patient engagement tools, and real-time tracking. Book a demo at SIIM 2025 to learn more.
- Make the Most of Your SIIM Experience with Mach7: See innovations from Mach7 Technologies in action at SIIM 2025. Schedule a demo of their industry-leading eUnity Enterprise Diagnostic Viewer or explore their groundbreaking UnityVue radiology solution. Reach new heights in imaging informatics with Mach7 at booth #514-516.
- Visit Enlitic at SIIM 2025: Visit Enlitic at SIIM 2025 at booth #530 to learn about their solutions for data standardization and migration, including their new partnership with GE HealthCare powering the data migration feature in GE’s new Genesis cloud portfolio. Book a demo today.
- Opportunistic Detection of CAC and Pulmonary Nodules: Achieve a newfound certainty of search for thoracic CT when using ClearRead CT from Riverain Technologies. It’s a natural addition for opportunistic CAC scoring and nodule detection, or as part of a CT lung cancer screening program.
- AI and Neuroradiology Workflow: How can AI add value to workflows in neuroradiology? Watch this on-demand video to learn from Blackford partners how AI can help, from assisting providers in managing acute stroke patients to the impact of CPT III codes in driving adoption of brain volumetric AI solutions.
- Visit Philips at ISMRM 2025: Philips will be showcasing its AI-driven connected imaging, optimized workflows, and integrated clinical solutions for MRI at ISMRM 2025. See their conference highlights or drop by at booth #D41.
- Book a Visage Demo at SIIM 2025: Visage Imaging is trailblazing medical imaging’s SaaS move to the cloud with an open cloud philosophy based on industry standards and multi-cloud support. Learn more by registering for a priority demo at SIIM 2025 or visit them at booths #627-631.
- Connect with Calantic by Bayer at SIIM 2025: Visit Calantic by Bayer at SIIM 2025 to learn how they are helping clinicians leverage radiology AI to enhance the patient experience. See their schedule of presentations or book at meeting today at booth #231-235.
- AI Enables Automated Cobb Angle Measurements: Gleamer’s BoneMetrics AI solution accurately predicted the Cobb angle of scoliosis patients with high accuracy compared to manual measurements made by clinicians. Learn more in this paper.
- A Pivotal Moment for Clinical AI Policy: In this episode of The Radiology Report podcast, Medality’s Daniel Arnold interviews Peter Shen of Siemens Healthineers about major developments in AI regulation and reimbursement, including the introduction of the Health Tech Investment Act (S.1399).
- Connect with Intelerad at SIIM 2025: Join Intelerad at booth #533 at SIIM 2025 to learn how they are redefining healthcare imaging with innovative solutions designed to provide a clear path to answers. Schedule your visit today.
- Intelligent Imaging Ensures Efficient Workflow: Learn how intelligent imaging can help address challenges in radiography workflow – such as higher workloads and fewer staff – in this downloadable white paper from Siemens Healthineers.
- Presenting Unboxing AI: Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on May 15 features Christopher McKee of Better Medicine – reserve your seat today.
- Give Patients a Clear Path to Accessing Medical Data: Clearpath is a simple integration that empowers digital delivery of medical records and images. Request a demo today to find out how you can ditch the disc and give your patients and third parties instant access to digital data.
- Perspectives on Cybersecurity in Medical Imaging: Healthcare organizations are a prime target for cyberattacks, so how can you proactively defend yourself against these threats? Learn how to protect your operations – and your patients – by watching this on-demand webinar from Merge.
- The Future of SmartTechnology: SmartTechnology is DeepHealth’s solution for bringing informatics and imaging systems closer together by embedding informatics into hardware, creating completely new workflows. Learn how it works in this interview with CTO Sham Sokka.
- AI-Automated Thoracic Measurements: AI-generated measurements from Us2.ai’s AI echo software had good agreement with expert cardiologists for detecting signs of aortic dilation in patients with aortic stenosis in a recent clinical study. Find out how well it worked on this page.
- MRI Access and the Cost of Inpatient Stays: Longer inpatient stays due to delayed MRI access are a long-standing and costly issue for hospital systems. Find out how STAGE from SpinTech MRI can reduce your MRI backlog and inpatient stays by shortening brain scan times by 30%.
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