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Radiology AI Approvals Near 1k, Doc Burnout, and Cyberattacks
July 14, 2025
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The FDA last week released the long-awaited update to its list of AI-enabled medical devices that have received marketing authorization. The closely watched list shows the number of AI-enabled radiology authorizations approaching the 1k mark.
The FDA has been tracking authorizations of AI-enabled devices going back to 1995, and the list gives industry watchers a feel for not only how quickly the agency is churning out reviews but also which medical specialties are generating the most approvals.
- But the last time the FDA released an updated list was August 2024, and recent turmoil at the agency had some observers wondering if it would continue the tradition – as well as whether it could stay on pace for new approvals.
Those fears should be assuaged with the new release. The numbers indicate that through May 2025 the FDA has…
- Granted authorization to 1.2k AI-enabled medical devices since it started tracking.
- Approved 956 AI-enabled radiology products, or 77% of total medical authorizations.
- Radiology’s share of overall authorizations from January to May 2025 ticked up to 78% (115/148), compared to 73% in the 2024 update, and 80% in all of 2023.
- GE HealthCare remains the company with the most radiology AI authorizations, at 96 (including recent acquisitions like Caption Health and MIM Software), with Siemens Healthineers in second place at 80 (including Varian).
- Other notable mentions include Philips (42 including DiA Analysis), Canon (35), United Imaging (32), and Aidoc (30).
In a significant regulatory development, the FDA said it was developing a plan to identify and tag medical devices that use foundation models, including large language models and multimodal architecture.
- The agency said the program would help healthcare providers and patients know when LLM-based functionality was included in a medical device (the FDA has yet to approve a medical device with LLM technology).
In another interesting change, the FDA dropped “machine learning” from the title of its list, apparently with the idea that “AI” was sufficient as an umbrella term.
The Takeaway
The FDA’s release of its AI approval list is a welcome return to past practices that should reassure agency watchers that recent turmoil isn’t affecting its basic operations. The LLM guidance suggests the agency may be changing its approach to the technology in favor of disclosure and transparency instead of more stringent regulation that could delay some LLM solutions from reaching the market.
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- Radiologists More Likely to Quit: A new AMA study confirms that physician burnout is on the decline – but radiologists are among the specialists reporting the highest rates. Researchers surveyed 18k U.S. physicians from 2023 to 2024, finding a drop in the number who said they had a moderate interest in leaving their job (32% vs. 36%). But “intent to leave” rates for radiologists were 39%, exceeded only by anesthesiology and vascular surgery (both 41%).
- Coaching Reduces Doctor Burnout: Meanwhile, a UCLA study found giving professional coaching to small groups of doctors reduced burnout rates almost one-third – while costing less than individual coaching. Researchers provided six one-hour coaching sessions to 79 internal medicine attending physicians over one year, finding that those getting group coaching had greater burnout reduction than those coached individually (30% vs. 13%), while the control group that didn’t get coaching saw an 11% increase. Group coaching was also cheaper than one-on-one sessions ($400 vs. $1,000 per doctor).
- Prostate MRI Surveillance Is Safe: A new study confirms that using MRI for active surveillance of men with stable prostate cancer is safe. Writing in a study in European Urology Oncology, researchers tracked outcomes for 719 men who got active surveillance including MRI and biopsy over five years. Only 5% experienced surveillance failure (defined as mortality, metastasis, or disease progression), with a 1% metastasis rate and no deaths from prostate cancer. Tumor histology – specifically cribriform Gleason grade 2 – strongly predicted surveillance failure (HR = 13).
- Imagion Gets Good News from FDA: MRI contrast developer Imagion Biosystems received positive feedback from the FDA on its plans for a phase 2 clinical trial of its MagSense HER2 technology. The feedback comes as part of the formal review process for FDA-approved clinical trials, and Imagion plans to file an Investigational New Drug application for the phase 2 study in the third quarter. Imagion is developing MagSense HER2 for assessing axillary nodal disease in patients diagnosed with HER2+ breast cancer.
- Bayer Submits Gadoquatrane for European Approval: Bayer has added Europe to the list of regions where it’s filed for marketing authorization of its gadoquatrane high-relaxivity MRI contrast agent, turning in an application to the European Medicines Agency. High-relaxivity agents can potentially be used at half the dose of conventional gadolinium-based contrast agents, reducing patient exposure to gadolinium. Bayer has already submitted gadoquatrane to regulatory authorities in the U.S. and Japan.
- Radiotracer Firm Raises $98M: In a Series A funding round that might make many AI start-ups jealous, Swiss radiopharmaceutical developer Nuclidium raised $98M to commercialize its copper-based theranostics agents. The funding will be used to advance development of the company’s copper-61 agent for PET diagnostic use and copper-67 for therapeutic oncology applications. Initial clinical results were presented at SNMMI 2025 and suggest they have better performance compared to current PET radiotracers.
- FDA Expands Use of Amyloid PET Agents: The FDA has expanded the clinical indications for three PET radiotracers used to detect amyloid plaque in patients suspected of Alzheimer’s disease. The expansion supports quantitative measurement of amyloid plaque as well as predicting cognitive decline, and applies to florbetapir F-18 (Amyvid, Eli Lilly), flutemetamol F-18 (Vizamyl, GE HealthCare), and florbetaben F-18 (Neuraceq, Life Molecular Imaging). SNMMI called the FDA’s move “a new era in diagnosing and treating” Alzheimer’s disease.
- Fujifilm Adds DR Automation: Fujifilm Healthcare Americas released new automation features for its FDR Visionary Suite digital radiography room designed to improve workflow for radiologic technologists. The upgrades include an Intelligent Camera Assist feature built into the system’s collimator that provides live patient views from the control room. SpeedLink automatically sets dose-saving protocols and collimation field size to the chosen exam, while an automated positioning guidance feature helps technologists avoid retakes.
- AI Detects Mammo Positioning Problems: Better patient positioning in mammography screening is the focus of a new study in Journal of Breast Imaging that found that AI can detect problems. Researchers used Densitas’ IntelliMammo algorithms to analyze 126k mammograms from two health systems, finding roughly similar rates between the institutions in mammograms that didn’t meet quality criteria (8.4% and 7.3%). The most common unmet positioning criteria were short posterior nipple line on CC views, inadequate pectoralis muscle, and excessive exaggeration on CC views.
- More X-Ray AI of Osteoporosis: The stream of studies using classic X-ray in combination with AI to detect osteoporosis is growing. In a new study in Journal of Clinical Densitometry, a group from Japan tested two osteoporosis detection algorithms, finding that a model that analyzed X-rays to assess bone density in the lumbar vertebrae had higher sensitivity than one focusing on the femoral neck (89% vs. 75%). Easier X-ray-based screening as an alternative to DEXA could improve low osteoporosis screening rates.
- Heartflow Plaque Tool Gets RBM Nod: Heartflow’s Plaque Analysis solution will be included in clinical guidelines from radiology benefits manager EviCore. The guidelines go into effect on October 1 and call for Plaque Analysis to be used in patients with acute or stable chest pain and 1-70% stenosis on cardiac CT angiography scans. The move is a boost for Heartflow by easing reimbursement for plaque quantification from commercial health insurers, who will make individual decisions on guideline adoption and timing.
- Cook Recalls Angio Catheters: Interventional device maker Cook is recalling some of its Beacon Tip 5.0 French angiography catheters after discovering that the device’s tip may separate during use. Patient harms can include catheter fragmentation and embolization, and could result in sepsis, vessel perforation, thrombosis, embolism, and possibly death. The company has reported three serious injuries but no deaths from the problem. Cook customers can check the FDA’s website to see if they are affected by the recall.
- Hospital Cyberattacks Double: The number of hospital cyberattacks and compromised patient records has risen sharply in the last five years. In a new review article, researchers documented 742 cyberattacks in 2023, double the 369 attacks in 2018. Meanwhile, the number of monthly compromised health records tripled in April 2024 compared to April 2023 (15.3M vs. 5.3M). The cost of healthcare data breaches has also increased 53% since the start of the COVID-19 pandemic.
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Building an Enterprise Imaging Ecosystem
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- The Future of Radiology: In this episode of The Radiology Report, Medality’s Daniel Arnold sits down with Marc Gosselin, MD, from Vision Radiology for a thought-provoking conversation on burnout, balance, and the future of radiology.
- Medical Imaging Data for Improved Research: The need for high-quality medical imaging data is crucial to drive advancements in diagnostics and treatment. Schedule a demo today to learn how Enlitic’s ENDEX for data standardization and ENCOG for data anonymization enable researchers to access superior data while optimizing resources.
- 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.
- Adding Digital Pathology to Enterprise Imaging: In this on-demand video from SIIM 2025 hosted by Mach7, watch as a panel of industry experts discusses how to add digital pathology images into a healthcare organization’s overall enterprise imaging strategy.
- Revolutionizing 3D Imaging: Learn how Visage Imaging is revolutionizing 3D imaging for radiology with its Visage Ease VP solution for the Apple Vision Pro headset in this video with Steve Deaton, director of customer experience.
- Start at the Source to Improve MRI: Looking for ways to improve MRI speed and image quality while addressing broader concerns in healthcare? The answer may lie in proven MRI physics in your existing scanner – learn how to unlock it with STAGE from SpinTech MRI.
- Easily Share Patient Images and Reports: Physicians can easily share patient images and reports from a personal worklist using Intelerad’s InteleShare Physician Portal. Discover how easily it works in this self-guided demo.
- 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.
- CT Tubes for Life: Never buy another X-ray tube for the life of your CT scanner with the Philips CT 5300*. Powered by the advanced vMRC tube, software-driven innovation, and the industry’s first detector designed for AI. Built for lasting performance and peace of mind. *Terms and conditions apply.
- Integrating AI into Clinical Practice: AI has the potential to revolutionize healthcare, but it requires a collaborative effort between clinicians and AI experts. In this micro-learning course from Calantic by Bayer, learn about the latest developments in healthcare AI.
- AI Tools for Lung Cancer Screening: CT lung cancer screening is gaining momentum around the world. Learn about AI-based nodule detection tools that can improve the accuracy of low-dose CT scans in this video from Riverain Technologies.
- AI-Powered Early Breast Cancer Detection: DeepHealth parent RadNet is expanding its presence in mammography AI with its pending acquisition of iCAD. Find out how the transaction will accelerate AI-powered early detection and diagnosis of breast cancer on this page.
- Validating AI at Scale: Radiology Partners leveraged CARPL to benchmark four MSK AI models, reducing ground truthing workload and enabling same-day validation. Learn how RadPartners benchmarked AI.
- New-generation Platform for Managing Multi-Omics Data: QP-Insights from Quibim is a new-generation advanced platform for the management, storage, and analysis of large-scale multi-omics data and medical images for clinical studies and research projects. Learn more on this page.
- Coming Soon – A New Era in Fluoroscopy: Siemens Healthineers has created something so groundbreaking, it may transform your fluoroscopy imaging: LUMINOS Q.namix is coming soon.
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