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ABUS Flies Solo for Screening | FDA Marker Warning
October 28, 2024
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Together with
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“To today’s radiology and medical AI entrepreneurs – keep pushing forward, because the work we’re doing now could bring unprecedented value and drive real change in healthcare and beyond!”
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Amine Korchi, MD.
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We’re proud to announce The Imaging Wire‘s first webinar: Transforming Radiology Reporting at 12 pm ET on Wednesday November 13! Reserve your spot today to learn about the technologies that are reshaping radiology reporting.
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Is breast ultrasound ready for use as a primary breast screening modality – without mammography? Maybe not in developed countries, but researchers in China gave automated breast ultrasound a try, with results that are worth checking out in a new study in AJR.
Mammography is unquestionably the primary imaging modality for first-line breast screening, with other technologies like ultrasound and MRI taking a supplemental role, such as for working up questionable cases or for women with dense breast tissue.
- But the standard mammography-dominated paradigm might not be suitable for some resource-challenged countries that have yet to build an installed base of X-ray-based mammography systems.
One of these countries is China, which not only has fewer mammography systems in rural areas but also has a population of women who have denser breast tissue, which can cause problems with conventional mammography.
- As a result, the Chinese National Breast Cancer Screening Program has adopted ultrasound as its primary screening modality, with women ages 35-69 eligible for screening breast ultrasound every 2-3 years. Mammography is reserved for additional workup.
But handheld ultrasound has challenges of its own. It’s operator-dependent, and image interpretation requires experienced radiologists – also in short supply in some Chinese regions.
- So the AJR researchers performed a study of 6k women who were screened with GE HealthCare’s Invenia ABUS 2.0 scanner, which uses ultrasound to scan women lying in the supine position. Images were sent via teleradiology to expert radiologists at a remote institution.
How did ABUS perform as a primary screening modality? The researchers found that after a single round of screening …
- ABUS had a cancer detection rate of 4.0 cancers per 1k women (4.4 for women 40-69).
- Sensitivity was 92% and specificity was 88%.
- Abnormal interpretation rate was 12%.
- 96% of detected cancers were invasive, and 74% were node-negative.
- Two interval cancers were detected (rate of 0.33 per 1k).
How do the numbers compare to mammography?
- The cancer detection rate in the Breast Cancer Surveillance Consortium study was 5.1 cancers per 1k women, so not far off.
The Takeaway
The results offer an interesting look at an alternative to the mammography-first breast screening paradigm used in developed countries, where ABUS is mostly used as a supplemental technology. For resource-challenged areas around the world, ABUS with teleradiology could solve multiple problems at once.
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Address the Hidden Impacts of Legacy Image Exchange Solutions
87% of healthcare leaders identified patient satisfaction as a challenge in a recent survey. Learn how healthcare providers are improving patient satisfaction in this article from PocketHealth.
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Revolutionizing Medical Imaging Data Management
Enlitic has acquired Laitek, and the combination creates new possibilities to revolutionize medical imaging data management. Learn more about Laitek and how its advanced migration services can benefit your radiology practice.
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Connecting Patients to Exceptional Care
Mach7 Technologies’ enterprise imaging solutions connect patients and clinicians across the globe to enable exceptional care. As modern healthcare evolves, so should your strategies. Schedule a demo at RSNA 2024 or stop by booth #3953 to learn more.
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- FDA Breast Marker Warning: The FDA on Friday issued a “do not use” warning for Hologic’s BioZorb radiography breast tissue marker due to reports of “serious adverse events” with the implant. The device was subject to a recall earlier in the year, but the new warning apparently is an escalation of the FDA’s oversight. In addition to not implanting any new markers, the agency advised providers to return any unused BioZorb lots to Hologic. Currently implanted devices do not need to be removed but patients should be monitored.
- Easier Prostate MRI Scanning: In a new study in European Urology, researchers found that a biparametric MRI scanning protocol without contrast for prostate cancer was easier to perform and wasn’t inferior to more complex multiparametric MRI. They compared bpMRI to mpMRI in 400 exams at European centers, finding that for detecting clinically significant prostate cancer they had similar AUROC (0.853 vs. 0.859), sensitivity (88.6% vs. 89.4%), and specificity (59% vs. 58%). The study confirms other recent papers on the effectiveness of bpMRI.
- FDA to Review Telix Brain Radiotracer: The FDA has accepted for priority review Telix Pharmaceuticals’ Pixclara (TLX101-CDx) fluorine-18 floretyrosine PET radiopharmaceutical for glioma imaging. The FDA classified Pixclara as an orphan drug and granted fast-track designation due to the lack of other options for amino acid PET for brain cancer. In other recent Telix news, the company said it would spin off its Rhine Pharma subsidiary as an independent company; Rhine is developing radiopharmaceuticals for imaging and treatment based on technetium-99m and rhenium-188.
- GE Touts PET/CT Milestones: GE HealthCare is highlighting several milestones for its Omni Legend PET/CT scanner. The company installed the 100th system in the U.S., at the just-completed UW Health Eastpark Medical Center in Madison, Wisconsin. In addition, GE said it would begin U.S. manufacturing of Omni Legend at a production line at its Waukesha headquarters, as well as continue to make the systems in China and Israel.
- Photon-Counting FFR-CT: Fractional flow reserve CT has value for assessing patients with suspected obstructive coronary artery disease, but what if you combined it with photon-counting CT? Researchers in a paper in European Journal of Radiology did just that, finding that ultra-high-resolution photon-counting FFR-CT values in 34 patients were higher than conventional CT on both a vessel (0.58 vs. 0.55) and patient (0.73 vs. 0.70) level. Two patients who had hemodynamically significant lesions (≤ 0.80) on conventional CT were reclassified as non-significant on photon-counting FFR-CT.
- Ezra Launches $6K Imaging Test: Whole-body imaging provider Ezra has launched a new screening test that combines MRI, CT, and AI, but at a price – a cool $5,995. Ezra Blueprint combines a full-body 3T MRI with low-dose chest CT to screen for cancer and 500 other health conditions in 13 organs, and takes place over two 60-minute appointments. Ezra partnered with longevity guru Bryan Johnson of Blueprint on the test, which could be pushing the limit of what consumers are willing to pay for wellness scans.
- Lung Screening Launch in Florida: A new lung cancer screening program has been launched in Florida that combines blood testing with CT scans. Primary care practices associated with the Florida Lung Health Coalition will offer eligible patients the FirstLook Lung blood test from DELFI Diagnostics; those whose results are “elevated” will be referred to CT scans at RadNet imaging centers. The program is a novel approach to improve on low lung screening adherence rates, which stand at 16% in Florida.
- Segmed Signs for Synthetic Data: The data may be synthetic, but the partnership is very real. Imaging data aggregation company Segmed is partnering with synthetic data generation firm Ryver.ai to generate synthetic data based on real-world imaging scans for training AI algorithms. AI developers have been turning to synthetic tools to meet the challenges of accessing enough data to train AI on a diverse range of conditions and patient populations. Segmed recently raised $10.4M to advance development of its Openda platform.
- Viz.ai Expands Lung Disease Offerings: AI developer Viz.ai is expanding its capabilities in lung disease. The company has added natural language processing capabilities to derive clinical insights from EHRs to supplement imaging AI and identify and manage patients with lung disease. The expansion will be added to Viz.ai’s AI-powered care acceleration platform.
- Annalise U.K. Lung Screening Debut: AI software for lung cancer detection from Annalise.ai will be rolled out in the U.K. as part of a new initiative funded by the AI Diagnostic Fund. Annalise AI tools will go into use at NHS hospitals in the North East and North Cumbria region, which serves 3M people with some of the greatest health inequalities in the U.K., such as a much higher incidence of lung cancer per 100k people than London (177 vs. 89 cases).
- deepc Scores NHS Agreement: AI platform company deepc has signed an agreement with the U.K.’s AI Centre for Value-Based Healthcare to deploy its deepcOS at NHS trusts. The center is working to promote faster AI adoption in the NHS system, and the partnership calls for the platform to be deployed initially at six NHS trusts with more to follow. Users will get access to over 75 regulatory-approved AI algorithms on deepcOS.
- Volpara’s Publishing Milestone: Volpara Health is highlighting a milestone for peer-review publications investigating its technology, with the 300th paper published. Two recent papers include a study showing that radiologists who reviewed mammograms sorted by breast density with the company’s software had better performance than those who didn’t. A second important paper from the U.K. used Volpara software to determine how breast density affects cancer detection.
- EchoPrime AI Model for TTE: A Cedars-Sinai led research team announced EchoPrime, the first echocardiography AI model capable of evaluating and interpreting a full transthoracic echocardiogram. The model was trained on 10X the data of existing echo AI models, including 12M videos of 275k echo-first studies from 108k patients. It also uses an “anatomic attention” model to rank different echo videos for identifying the most relevant views and producing the most accurate holistic interpretation for a study.
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The Clinical Value of Soft-Tissue Chest X-Ray
Soft-tissue techniques can improve the visibility and accuracy of chest X-ray. Learn about two important soft-tissue methods – bone suppression and dual-energy subtraction – in this white paper from Riverain Technologies.
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The Growth of AI in Pulmonology
Learn more about the capabilities of AI for chest imaging in this on-demand webinar from Blackford. You’ll hear pulmonology professionals discuss several promising areas, from acute imaging through chest X-ray analysis to lung cancer screening.
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AI Acceleration without the Hype
The Visage AI Accelerator program is an innovation magnet – an end-to-end AI solution that bridges research and diagnostic imaging on the same, unified platform. Learn how Visage 7 provides synergistic, smart workflows and flawless third-party AI integration.
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- 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%.
- Meet Merge at RSNA 2024: Merge is looking forward to sharing a wide range of news, innovations, and updates at RSNA 2024. Join us at booth #6100 to explore how our imaging solutions put your workspaces, clinicians, and transformation into focus.
- Rewriting Cancer: How AI Could Reimagine Cancer Screening: Find out how DeepHealth is empowering breakthroughs in lung cancer detection with AI-driven technology in the #RewritingCancer digital series, which explores innovative solutions for cancer prevention, diagnosis, and treatment.
- Request an RSNA Meeting with TeraRecon: RSNA 2024 will be here before you know it. Come explore TeraRecon’s latest updates and find out why the company is an award-winning solution provider for AI-empowered radiology, oncology, cardiology, neurology, and vascular surgery.
- Build Intelligent Connections at RSNA 2024: Visit AGFA HealthCare at booth #2565 at RSNA 2024 to learn how to elevate your radiology practice with enterprise imaging, enabling rapid growth. Find out how their next-generation solutions empower you to read faster and work smarter by scheduling an appointment today.
- Connect with United Imaging at RSNA 2024: United Imaging will be celebrating the theme of Building Intelligent Connections at RSNA 2024. Come visit the company at booth #1929 to learn about their imaging solutions and how they connect to United’s mission of Equal Healthcare for All.
- Redefining the Value of AI: Check out the next Road to RSNA virtual session from Microsoft at 2 pm ET on November 6 to discover how you can unlock value from your report data to improve quality, close the loop on patient follow‑up, and monitor AI performance.
- 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.
- Catch What You’ve Missed on Unboxing AI: Missed an episode of Unboxing AI, CARPL’s video series on AI in radiology? Check out all the past episodes on their YouTube channel.
- Focus on Mammography Workflow: Mammography workflow is key to providing high-quality breast imaging services. In this Imaging Wire Show, 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.
- Imaging Workflows that Actually Work: Not a fan of medical image exchange on discs? Then check out Clearpath and find out how it’s removing obstacles to better radiology workflow. Request a demo today.
- Drive Innovation in Healthcare: Harness the power of cloud for real-time analytics and operational efficiency with Optum’s fully managed, cloud-native enterprise imaging platform. Click here to transform your practice!
- Fully Automated AI for Mitral Regurgitation Grading: Echo AI can help address challenges with mitral regurgitation assessment quality and efficiency. Find out how researchers used Us2.ai’s fully automated echo workflow for grading MR severity and predicting one-year mortality.
- PACS that Scales to Fit Your Needs: IntelePACS from Intelerad streamlines your reading workflow from start to finish. With faster load times, centralized access, and integration with your EHR, it provides a smooth and efficient workflow your radiologists will prefer. Discover how IntelePACS can transform your radiology practice.
- Discover AI Apps Curated by Body Regions: Discover how Calantic Digital Solutions by Bayer supports you in tackling radiology challenges through multiple stages of the patient’s journey by offering AI solutions curated for specific body regions. Learn more about Calantic today.
- Transform Your Practice into a Multispecialty Powerhouse: Medality is the practice development platform that helps radiologists upskill in high-growth, advanced imaging areas. Request a demo today and discover how to transform your practice into a multispecialty powerhouse.
- Automated Weight-Bearing Foot Measurements: Learn how Gleamer’s BoneMetrics AI software was able to provide automated measurements on weight-bearing radiographs with high levels of accuracy in a paper published in Skeletal Radiology.
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