Bradley Erickson, MD, PhD.

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Artificial Intelligence

Getting Paid for AI – Will It Get Easier?

Reimbursement is one of the major stumbling blocks holding back wider clinical adoption of artificial intelligence. But new legislation was introduced into the U.S. Congress last week that could ease AI’s reimbursement path. 

For AI developers, getting an algorithm approved is just the first step toward commercial acceptance. 

• Perhaps even more important than FDA clearance is Medicare reimbursement, as healthcare providers are reluctant to use a product they won’t get paid for. 

Reimbursement drives clinical AI adoption, as evidenced by a 2023 analysis listing the top algorithms by CPT claims submitted (HeartFlow Analysis topped the list). 

• But CMS uses a patchwork system governing reimbursement, from temporary codes like New Technology Add-On Payment codes that expire after 2-3 years to G-codes for procedures that don’t have CPT codes, on up to the holy grail of medical reimbursement: Category I codes. 

The new legislation – S.1399 or the Health Tech Investment Act – would simplify the situation by setting up a dedicated Medicare coverage pathway for AI-enabled medical devices approved by the FDA (called “algorithm-based healthcare services”), as follows … 

• All FDA-approved products would be assigned a Category III New Technology Ambulatory Payment Classification in the HOPPS program.
• NTAPC codes would last for five years to enable collection of cost data before a permanent payment code is assigned. 
• Payment classifications will be based on the cost of service as estimated by the manufacturer. 

The bill at present has co-sponsors from both political parties, Sen. Mike Rounds (R-SD) and Sen. Martin Heinrich (D-NM). 

• The legislation has also drawn support from industry heavyweights like GE HealthCare and Siemens Healthineers, as well as industry groups like AdvaMed and others.

The Takeaway

The new bill sounds like a great idea, but it’s easy to be skeptical about its prospects in today’s highly charged political environment – especially when even bipartisan compromises like the 2025 Medicare fix got scuttled. Still, S.1399’s introduction at least shows that the highest levels of the U.S. government are cognizant of the need to improve clinical AI reimbursement.

Elevating Generative Reporting to the Web

Learn about the next leap in patient-focused diagnostic imaging with KailoFlow, the web-based evolution of Kailo Medical’s generative structured reporting platform that combines progress, innovation, and accessibility.

Which Imaging Vendors Are Ready for the Cloud?

Which medical imaging vendors are perceived as ready for the cloud? In a new survey from KLAS Research, AGFA HealthCare’s approach to the cloud won high marks from customers. Learn more about the report today.

The Leader in Molecular Imaging

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The Wire

• Multi-Cancer Detection with Whole-Body MRI: Screening whole-body MRI demonstrated multi-cancer detection capabilities in a study to be presented at AACR 2025 by Prenuvo researchers. The study included over 1k patients, all without a known cancer diagnosis at time of screening, and biopsy-proven cancers were detected in 2.2% of the total population via WB-MRI. Diagnostically motivated biopsies were performed in only 4.0% of cases, with more than half confirming cancer. WB-MRI also identified non-cancerous but clinically significant conditions requiring medical intervention.

• MRI Shows Opioid’s Fetal Impact: MRI scans of newborn babies showed the impact on brain development of opioids taken during pregnancy – even drugs like buprenorphine or methadone to treat opioid use disorder. In a study in JAMA Pediatrics of 269 newborns, newborns exposed to opioids had 5% smaller total brain volume on MRI, with reduced volumes across multiple brain regions. Authors called for more study on medications to treat opioid use disorder in pregnant women, as well as treating affected infants beyond initial withdrawal symptoms. 

• Bunkerhill Nets FDA Nod: A new AI-based tool for opportunistic screening of bone health is becoming available after Bunkerhill Health got FDA 510(k) clearance for its Bunkerhill BMD algorithm. The model enables clinicians to identify patients with low bone density from CT scans acquired for other clinical reasons. Providers can then refer these patients to additional evaluation, monitoring, and treatment. Bunkerhill BMD joins the company’s growing portfolio of opportunistic detection tools, including for coronary artery calcification and aortic valve calcification. 

• AI of CCTA Predicts MACE: A homegrown AI algorithm for CCTA developed by South Korean researchers predicted MACE among emergency patients in a new study in Radiology: Artificial Intelligence. Researchers tracked MACE over 2.5 years in 408 patients, finding that when combined with clinical risk factors like elevated troponin T scores, patients whose obstructive CAD was detected by AI had an 88X higher risk of MACE. Authors believe the value of their AI model is its applicability in the emergency setting.

• Brainomix Gets Stroke AI Clearance: Hot off raising $18M in a Series C round, Brainomix received FDA clearance for a new feature on its Brainomix 360 Stroke platform for helping clinicians assess ischemic core volume from non-contrast CT brain scans. Research has shown equivalency between the feature and CT perfusion and MRI core volume assessments, giving clinicians an alternative to more advanced imaging modalities.

• United’s Florida PET/CT Install: United Imaging installed its uMI Panorama PET/CT scanner at Florida Theranostics, a new facility serving the south Florida region that celebrated its grand opening last week. United highlighted the scanner’s high resolution (2.9mm NEMA PET resolution and sub-200ps timing resolution), large 76cm bore, and 700lb table weight capacity. It is the first uMI Panorama installation in Florida. 

• FDA’s Reversal on Remote Work: The FDA reversed its order that employees return to the office rather than telework remotely. An Associated Press story notes that the agency told drug and device reviewers they can work remotely at least two days a week, apparently due to concerns that recent layoffs and resignations “could jeopardize basic functions.” The story further notes that the FDA embraced telework a decade before it became routine at government agencies during the COVID-19 pandemic. 

• Annalise Scores Lung Screening Contract: Annalise.ai’s Enterprise CXR AI solution will be used by Lungscreen Australia to boost lung cancer detection at the provider’s sites in Australia. Enterprise CXR detects up to 124 findings on chest X-rays, including lung nodules from lung cancer or occupational lung diseases. 

• HHS Settles Radiology Data Breach Case: HHS settled a HIPAA investigation into Northeast Radiology (NERAD) over an alleged breach of protected patient data. The breach occurred from April 2019 to January 2020 in which unauthorized individuals accessed patient data on the radiology group’s PACS. HHS investigators said the group failed to conduct an adequate risk analysis, and NERAD agreed to pay $350k and implement a two-year corrective action plan. 

• Riverain Gets Ohio Install: Riverain Technologies installed its ClearRead CT solution at TriHealth in Cincinnati, which is using the technology as part of its CT lung cancer screening program. ClearRead CT removes blood vessels that can obscure nodules that could be lung cancer, giving radiologists a clearer view of thoracic anatomy.

• AI-Powered Lung POCUS for TB: Clinicians used AI to analyze point-of-care ultrasound scans as part of a tuberculosis screening program in Benin, Africa, finding that AI outperformed human experts. In data presented at ESCMID Global 2025, researchers used the ULTR-AI (max) suite of lung ultrasound algorithms in 504 patients, with the algorithm’s performance exceeding that of human experts for sensitivity (91% vs. 90%) and specificity (85% vs. 61%). AI-based POCUS offers easier triage of TB patients in low- and middle-income countries.

• GE’s Cincinnati Pediatric Partnership: GE HealthCare partnered with Cincinnati Children’s Hospital on a research collaboration to advance pediatric imaging across multiple modalities. The partnership will focus on areas like developing high-density MRI coils dedicated for children, AI algorithms for pediatric ultrasound, and pediatric PET and SPECT protocols. The collaboration falls under GE’s Care Innovation Hub concept for partnering with academic sites in targeted areas. 

• Mammo AI Quality Assurance: What’s the best way to measure performance when AI algorithms are updated to new versions? U.K. researchers tested two versions of Lunit’s Insight MMG mammography AI model against the PERFORMS program of test cases used for QA of NHS breast radiologists. They found no statistically significant difference between the versions (V1.1.7.1 and V1.1.8.1) in terms of AUC or sensitivity, showing that the same QA programs used for human readers can be used for regular monitoring of AI models. 

• Synthesis Updates PACS Software: Synthesis Health updated their PACS software to version 2.0, with the upgrade including a range of enhancements. Users can now log in to the Synthesis Core operation system using their local authentication methods, while the Synthesis Vision cloud-native viewer now automatically saves annotation changes. For mammography images, users can now switch between standard 2D and DBT views. 

• The Imaging Wire Top 40: Who are the top 40 resources in radiology that you should be following? In our updated (and expanded) list for 2025, we suggest the websites, news sources, and key opinion leaders that should keep you well-informed about healthcare’s top medical specialty. 

Ranked #1 Best in KLAS for 3 Consecutive Years

Named Best in KLAS 2025, Microsoft’s PowerShare earns praise from clinicians and other imaging stakeholders for seamless medical image exchange. Hear how it’s benefiting customers and patients.

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.

Perspectives on Cybersecurity in Medical Imaging

Healthcare organizations are a prime target for cyberattacks, so how can you proactively defend yourself against these threats? Learn how to protect your operations – and your patients – in this March 27 webinar from Merge by Merative.

The Resource Wire

• Stop Shipping Discs! By pivoting to a 100% digital fulfillment model for patient images and records, you can improve their experience while significantly reducing labor and shipping costs. Find out how on this page from Clearpath. 

• AI-Enabled DICOM Data Migration: What are the key elements of DICOM data migration? Visit this page for part 2 of Enlitic’s comprehensive guide, focusing on the critical steps of data extraction, normalization, and cleaning.

• Incorporating Digital Pathology in Your Enterprise Imaging Strategy: As digital pathology exams grow in size and complexity, healthcare organizations face increasing challenges. Attend this Mach7 Technologies webinar on May 8 to hear real-world experiences from the University of Michigan on how they unified radiology and pathology. 

• The Benefits of Operational AI: Explore the transformative potential of operational AI in healthcare in this on-demand webinar hosted by Blackford. Learn from the company’s partners how AI can help your practice operate more efficiently. 

• Leading the Way in AI Transparency: There’s a need to better inform radiologists about AI’s role when interpreting images and generating measurements. Visage Imaging’s Visage 7 can display text in the viewer indicating that AI was used as a diagnostic aid – find out how it works today. 

• Improve Patient Engagement with Clearer Imaging Insights: When patients better understand their imaging results, they’re more engaged and confident in their care. PocketHealth’s Image Reader adds anatomical visualizations to imaging records, improving comprehension, strengthening provider-patient relationships, and driving higher satisfaction. Learn more here.

• 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.

• A New Resource for AI of MRI: Gleamer is expanding into AI of MRI with its acquisition of innovative AI developers Pixyl and Caerus Medical. Learn how the company is creating the most comprehensive AI portfolio for medical imaging. 

• Clarity, Speed, and Confidence for MRI Efficiency: Radiologists have used a variety of methods to improve efficiency, but many of these methods come with drawbacks. Find out in this article how SpinTech MRI takes on the challenge of MRI efficiency with its STAGE software.

• 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.

• AI for Lung Cancer Diagnosis and Screening: Check out this comprehensive new eBook from Calantic by Bayer on the role of AI in lung cancer diagnosis and screening. It explores AI’s potential role in improving lung cancer screening strategies, identifying high-risk individuals, and enhancing diagnostic accuracy. Download it today.

• Get the 2024 Radiology Practice Development Report: Medality surveyed more than 3,300 radiologists fand discovered the most critical training gaps and growth opportunities in radiology for its 2024 Radiology Practice Development Report. Download your complimentary report today.

• How to Standardize CT Images: The quality and appearance of CT scans can vary considerably. In this white paper from Riverain Technologies, find out how image normalization can standardize CT images, making them easier to analyze and interpret. 

• What’s Next for AI for Cancer Detection? AI is transforming the fight against cancer by enabling faster and more accurate cancer detection. Read this article from DeepHealth to learn how the company is pioneering new ways to advance cancer screening and broader imaging-based care.

• Echo AI for Cardiac Amyloidosis: Echo can be used to diagnose patients with cardiac amyloidosis and differentiate them from those with left ventricular hypertrophy. Learn how Us2.ai’s novel solutions improve diagnosis of this underdiagnosed condition. 

• 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.

• Presenting Unboxing AI: Check out CARPL’s video series, Unboxing AI, featuring experts discussing AI and its future in radiology. The next episode on April 17 features Vytautas Naujalis of Oxipit – reserve your seat today. 

• Preparing for the Future of Enterprise Imaging: What do health IT and imaging leaders need to know about moving medical images to the cloud? Find out how to prepare for enterprise imaging’s future in this downloadable e-book from Optum. 

The Industry Wire

1. FDA shifts away from animal testing for drug development. 
2. Prospect’s beleaguered Penn. hospitals get last-minute lifeline. 
3. Medicare Advantage contracts squeeze rural hospitals.
4. ‘Chaos and questions’ at U.S. health agencies. 
5. NIH reverses conference attendance ban for scientists. 
6. Healthcare welcomes pause to tariff turmoil. 
7. Novartis to spend $23B on U.S. drug plants.
8. Medicare paid Medicare Advantage $38B for non-Medicare services.
9. Employers are willing to pay for anti-obesity meds.
10. One-third of maternal deaths happen long after delivery.