X-ray News Round Up – September 2024
Cranfield, UK, 7th September 2024 — In this monthly news roundup, we offer some of the latest news and developments impacting the X-ray market that have piqued our interest, including our thoughts on the implications for the market.?
Breast Imaging?
FDA rule to inform women about breast density
Starting September 10th, 2024, the FDA mandates that mammography facilities must inform women of their breast density. This new rule is designed to ensure women receive essential information after their breast cancer screening exams, as breast density can influence the effectiveness of mammograms and their risk of breast cancer. This is expected to drive women with dense breasts to seek supplemental screening exams, driving the uptake of modalities like ultrasound, MRI and contrast-enhanced mammography.
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Study reveals Digital Breast Tomosynthesis (DBT) to increase breast cancer detection rates compared to 2D digital mammography
The results of a technological comparison study conducted by professors at the Yale School of Medicine demonstrated DBT technology to have a cancer detection rate of 5.3% while 2D digital mammography had a rate of 4%. DBT also reduced the rate of advanced stage cancers — 32.7% versus 43.6% for 2D digital mammography, suggesting that DBT facilitates earlier cancer detection. In addition, the recall rates for DBT are claimed to be lower than that of digital mammography. However, DBT is not yet widely used for breast cancer screening exams due to a lack of approvals outside of the US. Despite this, many developed markets are purchasing DBT technology in anticipation of its approval for screening in the near-term, in addition to its growing use for diagnostic breast exams. The cost of the device and the time taken to interpret the images are additional factors to be considered by governing bodies before fully integrating DBT into their breast cancer screening programmes.
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Cost-effectiveness of AI for risk-stratified breast cancer screening - A UK based study
The results of a study that analysed the cost-effectiveness of integrating risk-stratified screening for breast cancer with an AI model into the UK’s National Breast Cancer Screening Programme was published in September 2024. The findings indicate that AI-driven, risk-stratified screening programmes are both cost-effective and beneficial in terms of quality-adjusted life years (QALYs) compared to current methods. The proposed schedule for screening exams varies from every six years for those at the lowest risk, biannually and triennially for those below and above average risk respectively, and annually for those at the highest risk. This approach is projected to provide significant annual financial benefits to the NHS, ranging from approximately ￡60.4 million to ￡85.3 million, depending on the QALY value. Even with minimal additional resources, the strategy could still yield an annual benefit of around ￡10.6 million. The study concluded that incorporating AI-guided, risk-based screening into the UK National Breast Cancer Screening Program is likely to be cost-effective, offering substantial health benefits at reduced costs, and recommends further prospective evaluation of AI in breast cancer screening.?
AI-integrated Screening to Replace Double Reading of Mammograms was conducted in Denmark
Another study conducted in Denmark, assessing the safety and workflow benefits of AI-integrated breast cancer screening. The results showed that AI could feasibly replace one, or both, radiologists from the standard double-reading workflow, though accuracy and workload varied depending on the deployment site. A triage-based approach yielded the best performance across all metrics.?
However, prospective trials are needed to validate these scenarios. These trials would focus on the clinical outcomes of AI-integrated screening and the impact of replacing either the first or second reader, considering their different levels of experience and accuracy. Iceland has already introduced AI into their screening programme to alleviate the burden of double-reading workflows on radiologist workload, which is an issue across much of Europe due to workforce shortages.
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领英推荐
Nanox launches a new portable X-ray solution
Nanox, launched Nanox.CONNECT, an ultra-portable X-ray solution.??The product is positioned to improve patient care in hospitals mainly in disaster hit areas and is already in use in Forte Medical, Ghana. It has long been speculated that cold-cathode X-ray tubes would be integrated into portable X-ray systems due to their lighter weight compared to traditional X-ray tubes. The Nanox.CONNECT could provide an additional but small revenue stream for Nanox as their proprietary cold-cathode technology, Nanox.SOURCE, may give them a competitive advantage in this market. Additionally, Nanox could synergise the system with their teleradiology and/or AI business to provide services such as TB screening to rural areas with little access to healthcare.?
AZmed build on their SimonMed partnership to bring their fracture detection AI to paediatric X-ray exams
European MedTech startup AZmed has received FDA 510(k) clearance for its Rayvolve solution, which detects fractures on paediatric X-rays. This follows their earlier clearance for adult fracture detection. The clearance was supported by a study with SimonMed Imaging, confirming Rayvolve’s high sensitivity and specificity. This milestone allows AZmed to expand its AI-powered medical imaging solutions in the US market, aiming to improve fracture detection and reduce clinician workload.
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DMS-Imaging launches their Discover EVO R+ FP C-arm
DMS Imaging has launched a new mobile C-arm solution, the Discover EVO R+ FP. This device features a Flat Panel Detector (FPD) and is designed to deliver high image quality at a lower dose. It also facilitates incorporation of their proprietary ADAM AI technology. Paired with the falling prices for FPDs, the C-arm market is experiencing a decline in image intensifier systems in favour of FPDs solutions. Smaller vendors are expected to follow-suit by overhauling their portfolio with FPD solutions and eventually discontinuing image intensifier systems.
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Naitive begins assessing their X-ray bone densitometry AI with the University of Iowa ???????????
University of Iowa Health Care and Naitive Technologies have launched a joint project to assess the diagnostic accuracy of OsteoSight. Osteosight is an AI solution with FDA Breakthrough Device Designation for identifying low bone mineral density (BMD) with existing X-rays images. The project aims to enhance early detection of osteoporosis, a condition affecting millions worldwide, by comparing OsteoSight’s accuracy to the current gold standard, dual-energy X-ray absorptiometry (DEXA). The study will use up to 2,500 hip and pelvic X-rays taken within 12 months of a DEXA scan and will also examine potential biases in the machine learning model. Patient involvement is a cornerstone of the study and patients will share their experience with the researchers at the University of Iowa to provide additional insights on the technology. This initiative aims to make the early detection of osteoporosis more accessible and improve patient outcomes.
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Signify Research’s most recent X-ray report released this month – the 2024 edition of the Breast Imaging Market report is now available for purchase. The 2024 X-ray Marketing Intelligence Service also includes analysis on the General Radiography and Fluoroscopy, Interventional and Surgical X-ray, and Flat Panel Detectors.?
Signify Research will also be publishing the Bone and Metabolic Health report in November 2024.
?We welcome further conversations on the trends specifically impacting the markets highlighted.?
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