X-ray News Round-Up – January 2025

Cranfield, UK, 3rd February 2025 — This month's news roundup provides insight into recent X-ray market developments and their potential implications for the industry.?

Siemens Healthineers Plan to Increase Angiography and CT Manufacturing in China?

Siemens Healthineers in expanding its presence in the medical imaging market with a $136 million investment into a R&D and manufacturing facility in China for CT and Angiography. This will further enhance Siemens Healthineers manufacturing and product development capabilities, as well as its market share in China through its localised production. The new site will cover 63,000m2 of land area, almost tripling the size of its existing Shenzhen facility, which is the only other facility to provide the complete MRI value chain and angiography R&D outside of Germany. The project is not expected to begin until 2027.

?The USPSTF Issue New Screening Recommendations for Osteoporosis Using DXA?

On the 14th January, the US Preventative Services Task Force (USPSTF) finalised its new recommendations on osteoporosis screening. The update is mostly in line with its previous 2018 statement, recommending the screening of women over 65, or post-menopausal women with at least one additional risk factor. However, the new recommendation states that screening exams can include DXA with or without fracture risk assessment. This edition also makes no mention of qUS, an ultrasound competitor to DXA, which was discussed in previous recommendations.

The new update may boost the uptake of axial DXA systems, however, this is unlikely given the low reimbursement of DXA in the US, posing a significant barrier to its further uptake. Furthermore, the recommendations still do not include screening for men, even those at high risk for osteoporosis, including those using glucocorticoids.?

NHS begins Health Technology Assessment of X-ray AI for fracture detection

The UK’s National Institute for Care Excellence (NICE) issued a Health Technology Assessment (HTA) for the investigatory use of X-ray AI to avoid missed fractures in NHS urgent care settings.

The HTA aims to research and identify several outcomes, including:

·??????? Fracture detection rate with AI

·??????? Cost per scan (which is estimated to be ~￡1 per scan)

·??????? Number of missed fractures before radiologist review

·??????? Recall rates after radiologist review

·??????? Rate of unnecessary referral to the fracture clinic

The HTA stipulated five AI solutions may be used:

·??????? BoneView (Gleamer)

·??????? qMSK (Qure.ai)

·??????? Rayvolve (AZmed)

·??????? RBfracture (Radiobotics)

·??????? TechCare Alert (Milvue)?

AI is still in its early adoption, and this research should better elucidate its cost, clinical utility, implementation methodology, and impact on the workforce/resources.?

OXOS Medical's MC2 Portable X-ray System Gains FDA Approval?

OXOS Medical recently secured FDA clearance for its MC2 X-ray system, a portable solution designed to enhance point-of-care diagnostics. The MC2 aims to simplify and streamline X-ray imaging, offering a user-friendly and efficient approach for healthcare professionals.? This regulatory approval enables OXOS Medical to introduce its technology to the US market, potentially expanding access to crucial diagnostic imaging and improving patient care. The company emphasises the system's safety, simplicity, and smart design, highlighting its potential to address the growing demand for accessible and effective imaging solutions. The MC2's entry into the market signals a growing trend toward portable and point-of-care X-ray solutions, potentially disrupting traditional imaging workflows and increasing access to diagnostics, particularly in underserved or remote areas.?

European Prospective Study Highlights the Power of AI in Mammography Screening?

The results of the PRAIM trial (Prospective multicentre observational study of an integrated AI system with live Monitoring) were released this January. The trial took place within Germany’s national mammography screening programme to assess the impact of AI to assist during at least one of the two mammography reviews, conducted by radiologists.?

A total of 463,094 women were screened, with around 260,000 receiving AI assistance during radiologist review using AI from the German AI vendor, Vara.ai. Ultimately, this group demonstrated a 17.6% increase in breast cancer detection rates. In addition, the recall rate was lower and determined to be non-inferior to the group receiving traditional mammography review.?

Several large-scale prospective studies, including this most recently completed trial, are reporting positive results, as seen in the MASAI and ScreenTrustCAD trials. There is undoubtedly growing momentum toward implementing AI in national mammography screening programs across Europe. For example, Iceland, Qatar, and New South Wales, Australia, has already implemented Lunit MMG in their breast cancer screening programs. However, questions remain regarding the cost and challenges of PACS integration, as well as liability, although countries like the UK are already investigating these issues.

?New product Approvals:?

On January 9th, Carestream announced the CE mark approval for its Focus HD X-ray detectors and the DRX-Rise mobile DR system. The Focus HD Detector line include 100μm pixel-pitch, which is becoming an industry standard for general radiography panels in developed markets like Western Europe.?

The DRX-Rise is a budget-friendly, lightweight mobile system with features such as assisted drive and double displays to enhance workflows. Carestream is already one of the leading vendors worldwide for mobile DRs and is especially strong in the US, its domestic market. This approval, as well as its recent distribution partnership with Examion in Germany, will bolster Carestream’s market share further in Europe, and strengthen its global position.?

The 2025 X-ray Marketing Intelligence Service also includes analysis on the General Radiography and Fluoroscopy, Interventional and Surgical X-ray, Flat Panel Detectors and Breast Imaging Market.?

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