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Top Radiology Trends for 2025 | FDA’s AI Guidance
January 9, 2025
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“Really encouraging to see such clarity from the FDA – they have clearly learned a lot over the past few years on what documentation and evidence is required to demonstrate a safe and effective AI device.”

Hugh Harvey, MD, on the FDA’s new guidance on AI regulation.

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Radiologists

Top Radiology Trends for 2025

There’s no question that 2025 will be a watershed year for radiology. AI is on the cusp of going mainstream, the radiologist shortage won’t go away, and a number of new U.S. regulatory initiatives promise to reshape the field. 

As we did in 2024, The Imaging Wire asked key opinion leaders in medical imaging to provide their predictions on the technologies, clinical applications, and regulatory developments that will shape the specialty for the next 12 months.

AI Blurs Lines with Generative Models: “Providers will interchangeably use both general-purpose and custom-built GenAI models for regulated (e.g., draft reporting) and unregulated (e.g., EHR summaries) tasks. This will blur current lines for medical device determination, shift performance testing from regulators to providers, and encourage regulators to define comprehensive clearance pathways for GenAI.” – Keith Dreyer, DO, PhD, and Bernardo Bizzo, MD, PhD, Mass General Brigham/Harvard Medical School

AI Focus on Reporting and Synthetic Data: “There will be continued interest in using generative AI for reporting and synthetic data alongside ongoing discussions about bias, fairness, and regulations. We can expect an increasing focus on automated draft report generation. I look forward to seeing the community explore radiology use cases for test-time compute and agentic AI.” Woojin Kim, MD, CMIO, Rad AI

Breast Density Reporting Now in Effect: “The FDA ‘dense breast’ reporting standard is now in effect; needed next is standardization of insurance coverage. Individual state insurance laws are inconsistent, and while a federal Find It Early Act did not pass in 2024, supporters will likely reintroduce the legislation in 2025 to ensure health plans cover screening/diagnostic breast imaging with no out-of-pocket costs for women with dense breasts or at higher risk for breast cancer.” – JoAnn Pushkin, executive director, DenseBreast-info

Breast Screening Based on Risk: “The future direction of breast screening will likely include AI to analyze mammograms and other screening imaging studies as well as patient health data rather than family history and lifestyle choices, allowing more accurate risk assessment. Patients will receive tailored screening recommendations, and imaging may include breast MRI, DBT with AI assistance, and other technologies to identify small high-grade aggressive tumors. Genetic testing results will help identify patients at high elevated risk, providing patients with accurate, clear information about their individual risk and engaging them with shared decision-making regarding benefits and harms of screening opportunities.” – Stamatia Destounis, MD, managing partner, Elizabeth Wende Breast Care 

MRI Safety Comes of Age: “2025 will be the year of MRI safety’s ‘coming of age.’ New CPT codes to reimburse providers for the additional effort required to ensure safe scanning of patients with implants are the first time a formal structure has been established to ensure at least some MRI safety. This CPT change isn’t a stand-alone revolution, but a bellwether of the ‘young adulthood’ of MRI safety and changes yet to come.” Tobias Gilk, founder, Gilk Radiology Consultants

New Era for CT Colonography: “A new era for CT colonography started on January 1, 2025, when CMS started coverage for colorectal cancer screening. Adding CTC as an option for CRC screening will ultimately save lives since it identifies precursor polyps as well as cancer. Expanding screening CTC to some of our most vulnerable patients – including African Americans, who have higher rates of colorectal cancer – will help to improve health disparities. Radiologists need to be prepared to handle increased CTC volumes to assure efficient and effective patient care.” – Judy Yee, MD, Montefiore Medical Center/Albert Einstein College of Medicine

Patients Discover AI for Medical Images: “Patients will use consumer-grade, multi-modal generative AI chatbots like ChatGPT to interpret their medical images and verify radiology reports for missed findings. Because they are not marketed for medical use, regulators will struggle to enforce oversight and could announce enforcement discretion for consumer use of these general-purpose AI models.” – Keith Dreyer, DO, PhD, and Bernardo Bizzo, MD, PhD, Mass General Brigham/Harvard Medical School

Radiologist Shortage Deepens:  “Maintaining proper staffing to support increasing volume will be the number one priority for private practices with hospital-based services in 2025. The shortage of radiologists is deepening, and with the demand for staffing growing so is the compensation package necessary to attract candidates. Private practices serving hospitals with weaker payor mix profiles will continue to seek financial support from their hospital partners to remain competitive in the market, not only to recruit new radiologists but also to retain current staff.” – Daniel Corbett, chief of business development, Radiology Business Solutions

Radiology in the Spotlight – for Better or Worse: “2025 will be the first year of Trump 2.0. Elon Musk and Vivek Ramaswamy will be busy beavering through the federal government. All attention will be on healthcare costs again. Radiology will be in the spotlight with calls to curb utilization, adopt AI, abolish fee-for-service, and adopt alternative payment models.” –  Saurabh Jha, MBBS, AKA RogueRad, Hospital of the University of Pennsylvania

Radiology’s Tough Economy Triggers Action: “I expect the global imaging market to look quite different at the end of 2025 versus the start, as tough economic conditions trigger action: M&A of small and mid-size hardware innovators; consolidation in imaging AI with category leaders emerging; the growing influence of non-imaging actors (pharma and life sciences, imaging service providers, big tech); price competition biting for the largest hardware vendors in emerging markets; and speculatively, at least one multi-billion top 20 vendor ‘mega-merger.’ Buckle up!” – Steve Holloway, CEO, Signify Research     

Regulation and Reimbursement: “Reimbursement decreases and recruitment challenges persist in 2025. While it remains critical that radiologists continue to advocate for the specialty and diversify their business plans, it’s becoming increasingly important for hospital-based groups to understand the fair market value of their services and potentially negotiate for additional support.” – Sandy Coffta, VP of client services, Healthcare Administrative Partners

Reimbursement Aids Nuclear Medicine Access: “In 2025, CMS reimbursement policy adjustments are expected to increase nuclear medicine usage and patient access. Ongoing clinical trials will likely drive approval of new radiopharmaceutical therapies and theranostics. With the radiopharmaceutical market projected to reach $12.4B, we expect improved access to nuclear medicine diagnostics and treatments in oncology, neurology, and cardiac imaging.” – Cathy Sue Cutler, PhD, SNMMI president and chair/Brookhaven National Laboratory

The Takeaway 

Making predictions is never easy, and that’s particularly true in a discipline as dynamic as radiology. Whatever happens in 2025, you’ll be sure to read all about it in The Imaging Wire. 

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The Wire

  • FDA Posts AI Guidance: The FDA this week released a major draft guidance explaining its regulation of AI- and machine learning-enabled medical devices, focusing on lifecycle management and marketing submissions. The guidance is designed to help AI developers understand the documentation and information FDA will need to review product submissions, and is part of the agency’s effort to regulate the total product life cycle (TPLC) of AI-enabled devices, which can be challenging as AI algorithms can change following regulatory approval. The draft guidance also addresses AI bias and transparency. 
  • Updates to FDA’s AI Post-Market Plans: Meanwhile, digital health expert and former FDA staffer Brendan O’Leary has released an updated list of medical devices with predetermined change control plans. FDA established the PCCP program to enable vendors to make post-market changes to devices without having to file for a new regulatory review – a particularly important consideration for AI algorithms. So far, device and software developers have submitted PCCP plans for 53 products, 25% of which (13) are for radiology applications.
  • AI Boosts Breast Screening: In another study supporting the use of AI for breast screening, researchers in Germany used AI to support interpretation of screening mammograms. In the PRAIM trial in Nature Medicine with 463k women, radiologists using Vara’s Vara MG algorithm had an 18% higher cancer detection rate (6.7 vs. 5.7 cancers per 1k women) compared to conventional double reading, with a slightly lower recall rate as well (37 vs. 38 per 1k women). Positive predictive value of recall was also higher (18% vs. 15%). 
  • ScreenPoint Buys Risk Analysis Firm: ScreenPoint Medical acquired Biomediq, a Danish developer of texture analysis algorithms that enable quantitative breast cancer risk assessment. Biomediq’s Mammography Texture Risk biomarker recognizes breast tissue texture that can be associated with short- and long-term breast cancer risk. The companies have been collaborators for a decade, and the acquisition will bring risk assessment capabilities to ScreenPoint’s Transpara mammography AI algorithm. 
  • Teleradiology Consolidation: Teleradiology provider ONRAD has acquired Direct Radiology from Philips, expanding its network to provide medical image interpretation services to over 550 U.S. healthcare facilities. Philips acquired Direct Radiology in 2019 as a complement to its radiology device business. Direct Radiology will remain intact and operate as a subsidiary of ONRAD, adding 80 radiologists to nearly double ONRAD’s team. 
  • Qure Partners with Cerebriu for Stroke AI: Qure.ai is bolstering its AI stroke detection capabilities by adding Cerebriu’s MRI solution to its offering. Cerebriu’s MRI triage capabilities will be added to Qure’s stroke care package, which includes the Qure App for collaboration between care teams and qER for AI interpretation of brain scans, giving clinicians access to insights from non-contrast CT, CT angiography, and MRI scans. Cerebriu specializes in MRI workflow automation by detecting critical findings and notifying clinicians. 
  • MRI Links Airport Noise to Heart Issues: MRI helped researchers determine that people living near noisy airports had nearly four times the risk of major adverse cardiac events compared to those who didn’t. In a paper in JACC, researchers reviewed MRI scans of 3.6k people from the UK Biobank study, finding those living near higher airport noise had 10-20% worse heart structure and function, probably due to sleep disruption. Further analysis found that a hypothetical person living near a noisy airport would have almost 4X the risk of MACE.  
  • New Guidelines for Tau and Amyloid PET: SNMMI and the Alzheimer’s Association this week issued the first new appropriate use guidelines in over 10 years for the use of PET to detect Alzheimer’s disease. The guidelines update advice for the use of amyloid-detecting radiotracers, and add support for tau PET, important considerations given recent FDA approvals of radiopharmaceuticals for both substances. Seven clinical scenarios were deemed appropriate for use of amyloid PET, while tau PET was recommended for five scenarios. 
  • Aetna Sues Radiology Partners: Aetna filed a lawsuit against Radiology Partners, accusing the national radiology network of using the federal No Surprises Act’s independent dispute resolution process to bill for services inappropriately. Aetna charges that Radiology Partners funneled billing disputes for out-of-network services through its Mori, Bean, and Brooks radiology group in Florida that should have been submitted through groups that were in-network providers for Aetna. RP executives respond that independent IDR arbitrators have sided with MBB in 98% of the disputes that have a final ruling. 
  • Earlier Breast Screening Saves Money: As Canada continues to tussle over whether to lower the national starting age for mammography screening, a new study in JAMA Network Open claims that screening Canadian women with digital mammography biennially from ages 40-74 would save the public health system CAD$50k per death averted. Annual screening was also cost-effective (savings of CAD$26k) and had the best breast cancer outcomes. Most of the savings derived from starting treatment earlier. A federal report last month recommended lowering the age despite an advisory group’s reluctance. 
  • 4DMedical’s Fibrosis Clearance: 4DMedical’s Imbio subsidiary has received FDA clearance for IQ-UIP, a new solution for identifying imaging findings related to fibrotic lung disease. The algorithm analyzes CT scans to detect findings suggestive of interstitial lung disease and generates a quantitative score that can be used to predict the risk of diseases such as lung cancer. 4DMedical acquired Imbio in December 2023. 
  • Cardiology Groups Settle Radiopharma Cases: The U.S. government has settled a series of cases with cardiology groups accused of overbilling Medicare for diagnostic radiopharmaceuticals. Sixteen separate cardiology practices across 12 states agreed to pay a total of $17.8M to settle allegations that they inflated their costs for purchasing radiopharmaceuticals in claims sent to Medicare. Radiopharmaceuticals like sestamibi and tetrofosmin – used for cardiac SPECT – made up the bulk of overbilling. For a full review of the story, check out our sister site CardiacWire. 
  • Cancer Screening Dropped During COVID: A new study documents the frightening drop in cancer services that occurred during the COVID-19 pandemic. In a new paper in Nature Cancer, researchers performed a literature review of studies on worldwide disruptions in cancer services, finding declines in cancer screening participation (-39%), cancer diagnoses (-23%), diagnostic procedures (-24%), radiation therapy (-15%), and systemic treatment (-35%). Declines were higher in medium-income countries compared to high-income nations. The study raises the question of whether a surge of late-stage disease is on the horizon.

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The Resource Wire

  • Top-Tier Care at Rural Hospitals: Holzer Health System in Jackson, OH, treats local patients like family. In this video, learn how United Imaging equipped Holzer Health with its uMR 570 MRI scanner, helping them to offer top-tier care.
  • Taking a Holistic Medical Imaging Approach: Blanchard Valley Health System in Ohio built a comprehensive holistic imaging strategy, focused on optimizing clinical workflows and easing user adoption. Learn how they did it with support from Merge in this white paper.
  • 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.
  • Image Sharing to Improve Patient Outcomes: In this case study, learn how AdventHealth improved treatment planning and delivery because of Microsoft’s PowerShare’s immediate connection to other sites in the network for medical image sharing.
  • An Enterprise Imaging Platform to Grow: WakeMed Health & Hospitals in North Carolina is home to award-winning chest pain centers and two nationally accredited, award-winning stroke centers. Find out how WakeMed turned to enterprise imaging solutions from AGFA HealthCare to transform the way their clinicians work. 
  • Harnessing the Power of AI to Improve Patient Care: Endeavor Health is one of the first healthcare providers in the Midwest to use AI in the echocardiography lab. Learn how they are harnessing echo AI’s tremendous potential to improve diagnostic capabilities and help patients on this page from Us2.ai.
  • Say Goodbye to On-Premises Costs: Free up resources with Optum’s cloud solutions for medical imaging that will help you say goodbye to on-premises costs. Visit this page to see how they can help you save!
  • 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.
  • Presenting Unboxing AI: Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on January 9 features Brian Casey of The Imaging Wire  – reserve your seat today. 
  • Fast and Reliable Head CT Imaging: Whether portable in the ICU or mobile in the ambulance as a mobile stroke unit, SOMATOM On.site from Siemens Healthineers brings critical care imaging to your patients. With the first-of-its-kind telescopic gantry design, integrated positioning accessories, and proven SOMATOM technologies, you can achieve fast and reliable CT head imaging.
  • 2 Questions about AI for Radiology Leaders: Are today’s radiology AI solutions solving the right problems? And are there other solutions available for AI of brain MRI? Read this article from SpinTech MRI to learn how their STAGE solution can optimize MRI utilization. 
  • LDCT Screening: To Scan or Not to Scan? Lung cancer accounts for more cancer deaths than prostate, ovarian, and breast cancer combined, but low-dose CT lung screening is catching on. Learn how tools like Intelerad’s InteleScreen can help you provide lung cancer screening with better nodule tracking and navigation. 
  • AI for Pediatric Fracture Detection: Pediatric fractures are common but can be easily missed on radiography. Meanwhile, AI tools for fracture detection have mostly been tested in adults. Learn how Gleamer’s BoneView AI solution helped clinicians find fractures in kids in a recent research study. 
  • Feel the Freedom of Helium-Free MRI: Lift limitations and experience MRI excellence with Philips BlueSeal, the industry’s lightest, vent pipe-free, high-performance, helium-free 1.5T scanner. Save on helium and energy costs, achieve precise AI-enhanced diagnoses, enjoy faster scans, and optimized workflows. Learn more today.
  • 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. 
  • Challenges and Opportunities in Radiology: In this episode of Medality’s The Radiology Report podcast, Medality CEO Daniel Arnold interviews Glenn Kaplan, MD, about the challenges and opportunities in radiology, including workforce shortages and capacity issues, and possible solutions.
  • 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!
  • 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.

The Industry Wire

  1. The 8th annual Shkreli Awards for healthcare’s worst behavior.
  2. HHS proposes HIPAA update to boost cybersecurity.
  3. AdventHealth names first Chief AI Officer.
  4. Scripps, Anthem network split impacts 125k members.
  5. Online scammers offer fake jobs at Michigan health system.
  6. 25 hospital closures in 2024.
  7. Children’s National taps Microsoft to prototype AI tools.
  8. FTC warns 21 healthcare marketers against deceptive practices.
  9. Epic’s priorities for the new year.
  10. HealthTap lawsuit alleges VC firm manipulated valuation for takeover.

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