Volpara Health CEO Teri Thomas, on new FDA rules on breast density.

Mammography workflow is being recognized as a key element in providing high-quality breast imaging services. In this Imaging Wire Show interview, we talked with Christie Devine of Siemens Healthineers about how recent advances in mammography workflow are leading to more effective mammography technologists — and happier patients.

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Breast Imaging

Why the FDA’s Density Rule Matters

The FDA’s new rules on reporting breast density to women getting mammograms went into effect on September 10. The implementation has been expected for some time, but this week’s rollout generated a wave of positive press coverage that highlights the importance both of breast density awareness and of breast screening.

The FDA in March 2023 said it would implement a national standard requiring providers to inform women of their breast density, which can obscure lesions on conventional X-ray mammography. 

• Breast density is also a risk factor for cancer, and patient advocacy groups had been pressuring the FDA to set a standard to replace what has become a patchwork of state-by-state notification rules. 

The FDA’s rules have been incorporated into the Mammography Quality Standards Act, and require that … 

• Mammography reports include a plain-language patient summary with “an overall assessment of breast density.” 
• The summary must include specific language that defines breast density, explains its ramifications for detection and cancer risk, and suggests the need for additional imaging tests.

A novel aspect of the new rules is that they were mostly driven by patients – women like JoAnn Pushkin and the late Nancy Cappello who as patients discovered first-hand the shortcomings of X-ray-based mammography for women with dense breast tissue. 

What’s next? Density-awareness proponents are now turning their attention to reimbursement, which for supplemental imaging is inconsistent across the U.S.

• A fix for the problem – the Find It Early Act – is working its way through Congress, and women’s health advocates lobbied on Capitol Hill this week to try to push the legislation through before the end of the current Congressional session. 

The new reporting landscape also creates opportunities for better software tools to detect and manage breast density and better predict risk in patients with dense breast tissue. 

• Clinicians already realize that women with dense breasts not only need different screening modalities like MRI and ultrasound, but that they might also require more frequent screening due to their heightened cancer risk. 

The Takeaway

The FDA’s new breast density rules matter for a variety of reasons, from showing the power of patients to change their imaging experience to outlining a future in which risk plays a more prominent role in breast screening. While more work remains to be done, this is a good time to savor the triumph.

AI-Based X-Ray Fracture Analysis

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Outsmarting the Radiology Workflow Management Problem

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The Wire

• MRI of COVID Lockdowns on Brain Aging: It’s no secret the COVID-19 pandemic was hard on young people, but a new study used MRI to prove it. In a paper in PNAS, brain MRI scans showed accelerated thinning of the cerebral cortex – an indication of faster brain aging – in adolescents who experienced pandemic lockdowns. In post-pandemic MRI scans of 54 kids ages 12-16, researchers found accelerated brain aging of 4.2 years in girls and 1.4 years in boys. The variance could be due to gender differences in social interaction. 

• Paragon Partners with Mach7: Paragon Health IT’s pivot from consulting firm to healthcare IT software provider took a big step forward this week with the signing of an alliance with Mach7 Technologies. Paragon will provide Mach7 with its Strings data analytics software for collecting and analyzing data generated across healthcare enterprises; Mach7 customers will be able to automate workflow, centralize system monitoring, track performance, and better integrate their VNA beyond DICOM files with tighter EMR integration. 

• Semaglutide Changes Body Composition: Body changes are also being caused by the new generation of diabetes and weight-loss drugs like semaglutide (Ozempic). A new study in AJR used abdominopelvic CT and AI quantification software developed at the University of Wisconsin to analyze body composition of 241 people treated with semaglutide, finding that those who lost weight saw declines in metrics that could reduce cardiometabolic risk, like visceral adipose tissue area (341 to 309 cm²), subcutaneous adipose tissue area (411 to 371 cm²), and muscle area (193 to 179 cm²). 

• Earlier Detection with Lung Screening: Ten years of CT lung cancer screening at a community hospital in Indiana has produced a marked shift toward detection of more early-stage cancers. In a talk at WCLC 2024 this week, researchers described how they achieved screening uptake over 60% for the past three years among people eligible under USPSTF 2021 guidelines thanks in part to nurse navigators who facilitate communication and streamline patient care. Detection of stage I disease has risen to 79% year to date compared to 51% in 2021, while late-stage cancers have declined 23%.

• Better Lung Screening Criteria: Some lung screening proponents believe that criteria based on smoking duration rather than pack-year intensity could save more lives, especially among under-represented minorities. Another talk at WCLC 2024 examined this question, finding that among 105k people with smoking histories, using criteria based on smoking duration rather than USPSTF 2021 guidelines reduced racial disparities as measured by eligibility-to-incidence (E-I) ratio. Duration-based criteria had an E-I between Black and White individuals of 13.6 vs. 19.3, an improvement over 9.5 vs. 20.3 found with USPSTF 2021.  

• Lung Screening with Smoking Cessation: Adding smoking cessation advice to CT lung cancer screening improved quit rates in a WCLC 2024 study. In 153 people, researchers tested a digital health aid with video counseling, nicotine replacement therapy, and digital personal stories versus standard care (brief advice and referral to a quit line); the digital health aid produced higher tobacco abstinence rates than standard care at three months (52% vs. 20%) and six months (43% vs. 13%), as well as higher six-month lung screening completion rates (47% vs. 23%). 

• NLP Helps Lung Nodule Follow-Up: Identifying which suspicious lung nodules need to be followed up can be a challenging task. Researchers from Brazil told attendees at WCLC 2024 how they developed natural language processing (NLP) software to analyze 67.6k chest CT reports at 11 hospitals; NLP identified 1.2k cases (1.8%) that required follow-up. At one hospital, 1.3% of scans were identified, and 65% of patients got specialist consultations that led to 14 patients getting CT-guided biopsy and surgical treatment for eight. 

• AI of X-Ray Lung Screening: Chest X-ray isn’t used for lung screening in most developed countries, but it could be an option for less developed nations without access to CT – especially if AI can help. In another WCLC 2024 talk, researchers from Thailand used Qure.ai’s qXR AI algorithm in 77 people who got chest radiographs for various conditions over a one-year period and were later diagnosed with lung cancer. AI detected lung cancer in 18%, which researchers classified as missed lung cancers, showing AI can help detect hidden disease. 

• AI for Fracture Detection: Gleamer’s BoneView AI fracture detection algorithm is being investigated by radiologists in the U.K.’s NHS to detect fractures on X-rays. The FRACT-AI study is currently underway and involves using AI to analyze 500 radiographs of all bones except the skull, facial bones, and cervical spine; 50% of the cases are abnormal. BoneView’s accuracy for detecting fractures will be evaluated against ground truth as established by radiologist interpretation. The FRACT-AI’s study protocol was recently published by BMJ Open. 

• deepc to Be Deployed in Norway: German AI platform company deepc’s deepcOS solution will be deployed in a region of Norway through a contract secured by its distribution partner Nordic Medtech. The contract is with Helse Sør-Øst RHF, the largest of the four regional health authorities in Norway that covers 57% of the country’s population, and is being called one of the biggest radiology AI tender offers in the Nordic region. Separately, deepc partnered with IST Medical for distribution of its platform in Germany, Spain, and Portugal. 

• Imaging IT Firms Nab Telerad Contract: Imaging IT companies InsiteOne, NewVue.ai, and RADPAIR have landed a contract to provide radiology workflow orchestration, cloud-native PACS, and reporting solutions to teleradiology provider Aligned Radiology. The contract illustrates the novel alliance between a pair of new faces on the imaging IT scene – NewVue and RADPAIR – with one of the field’s most venerable brands, InsiteOne, which has been revived under new management. 

• FDA Updates List of AR/VR Devices: The FDA updated its list of augmented reality/virtual reality devices that have received regulatory authorization. With 69 products, the list is quite a bit smaller than the 950 artificial intelligence/machine learning devices the agency has authorized – in fact, just six AR/VR products were authorized for the first six months of 2024 (three of those were classified as radiology products). More recent clearances include an augmented reality application from Sira Medical and Brainlab’s mixed reality viewer.

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AI for Lung Cancer Diagnosis and Screening

Check out this comprehensive new eBook from Calantic by Bayer on the role of AI in lung cancer diagnosis and screening. It explores AI’s potential role in improving lung cancer screening strategies, identifying high-risk individuals, and enhancing diagnostic accuracy. Download it today.

The Resource Wire

• The UK’s Lung Cancer Screening Rollout: The UK has launched a targeted lung cancer screening program to improve lung cancer outcomes through earlier detection. Learn how DeepHealth’s Saige Lung is the preferred AI solution in this case study. 

• Advances in Fully Automated Echocardiography: Echocardiography is a pillar of cardiac imaging, but it is operator-dependent and time-consuming to perform. Learn how new echo AI-based software from Us2.ai can automate image acquisition and calculate dozens of measurements that previously had to be performed manually.

• Creating a Theranostics Center of Excellence: See how Siemens Healthineers can work with you to create a radiopharmaceutical therapy center of excellence that’s built around your needs by providing consulting and design services that put you on the path to success.

• Unlock Medical Imaging’s Full Potential: Unlock the full potential of medical imaging with the power of cloud technology and discover how Optum’s solutions can streamline operations, enhance data security, and improve patient outcomes. Embrace the future of medical imaging today and see the difference the cloud can make!

• Give Your Patients the Experience They Want: Empower patients to take control of their healthcare journey by giving them mobile access to their records and images with Clearpath, the world’s first digital fulfillment platform for records and films. Book a demo today. 

• Unlocking Value in Healthcare: How can the Value Realization Pyramid help you unlock value from your technological investments? The pyramid outlines how high-quality data from advanced technologies like AI can drive enterprise-wide workflows and better decisions. Learn more on this page from Enlitic. 

• Improving Your Mammography Workflow: Want to learn how AI can relieve pressure in your mammography department? Watch this on-demand webinar hosted by Blackford featuring a panel discussing the importance of assessing breast density, image quality reporting, and prioritizing studies. 

• Visage Brings Relief: Hear Dr. Ron Shnier describe how the ultrafast speed in Visage Imaging’s Visage 7 brings him closer to referring physicians – even while reading remotely. 

• Presenting Unboxing AI: Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on September 13 features Hugh Harvey, MD, of Hardian Health – reserve your seat today. 

• Fill the Gaps of Legacy Solutions and Solve Healthcare Challenges: 69% of imaging leaders cited the costs and time of burning CDs as a major concern. Get more insights from a recent survey of imaging leaders and learn how healthcare providers are overcoming common challenges in this article from PocketHealth. 

• Next-Generation Enterprise Imaging: U.S. healthcare organizations are making a definitive pivot to cloud technology. In this white paper from AGFA HealthCare and HIMSS, learn about the benefits of cloud-based enterprise imaging. Download the white paper today. 

• How to Standardize CT Images: The quality and appearance of CT scans can vary considerably. In this white paper from Riverain Technologies, find out how image normalization can standardize CT images, making them easier to analyze and interpret. 

• How McFarland Clinic Reduced Downtime: McFarland Clinic Health Ventures recently experienced a downtime occurrence when an HL7 interface went down. But thanks to a suite of medical imaging solutions from Merge by Merative, McFarland’s downtime lasted all of 15 minutes. Find out how they did it in this case study.

• Set a New Standard of Care: Give your patients clarity and peace of mind with Prenuvo’s advanced whole-body MRI scans. Prenuvo’s team works closely with you to help pinpoint potential problems, diagnose faster, and deepen your patient relationships. Learn more today.

• Your In-Workflow Copilot Experience: Nuance’s PowerScribe Smart Impression harnesses generative AI to automatically generate draft impressions and recommendations, saving you time and reducing workload-related stress. Learn how it can become your in-workflow copilot today. 

• AI-Empowered CT Workflow: CT systems from United Imaging are designed for high image quality and low dose, and their AI-empowered workflow enables fast and reproducible positioning, helping you image patients with confidence. Learn more on this page.

• An End-to-End AV and AI Solution: Never buy separate AV and AI solutions again. Get in touch with TeraRecon to find out how your health system can benefit from all the Intuition clinical features you need, plus a growing list of exclusive subscription-only content that leverages the power of AI.

The Industry Wire

1. MGB unveils unified cancer care strategy.
2. Apple adds sleep apnea to Apple Watch, hearing aid to AirPods Pro.
3. NYU Langone performs first fully robotic lung transplant. 
4. Over 1k U.S. counties have no birthing facilities or obstetricians.
5. Allegheny Health serves as backdrop for TV drama, The Pitt.
6. UVA faculty demands removal of CEO and dean, leaders push back.
7. Researchers propose replacing BMI with body roundness index.
8. One-fifth of COVID deaths attributed to strained hospital caseloads.
9. Modesto’s Stanislaus Surgical Hospital to close after Medicare removal.
10. Nearly 50M people have been insured through the ACA exchanges.