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FDA Updates AI List, HIMSS Highlights, and Predicting AI’s Value
March 12, 2026
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Together with
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“Clinicians don’t trust AI they can’t explain – and they shouldn’t. At #HIMSS26, the conversation is shifting from ‘AI can do this’ to ‘AI you can stake a patient’s life on.’ Trusted clinical AI isn’t a feature. It’s the foundation.”
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Health technology influencer Evan Kirstel, from HIMSS 2026.
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The FDA last week updated its list of cleared AI-enabled medical devices, with the new list showing AI marketing authorizations through the end of 2025. The updated list reveals that radiology is maintaining its lead as the medical specialty with the most clearances.
The FDA’s previous update featured data through the end of September 2025, and showed the number of AI-enabled medical devices for radiology crossed the 1k mark. The new numbers show continued momentum for medical imaging.
- The agency’s data go all the way back to 1995 (the first cleared radiology device on the list was ImageChecker from R2 Technology/Hologic in 1998).
The new list tracks authorizations through the end of December 2025, and indicates the agency has…
- Authorized 1,451 AI-enabled medical devices since it began keeping track in 1995.
- Approved 1,104 radiology devices, or 76% of total AI-enabled medical authorizations.
- In the fourth quarter of 2025, the FDA cleared 72 AI-enabled medical devices, of which 55 (76%) were radiology devices.
- For all of 2025, radiology secured 75% of authorizations, compared to 73% for all of 2024 and 80% for 2023.
- GE HealthCare retained the top spot as the company with the most radiology AI authorizations at 120 (including acquisitions Bay Labs, BK Medical, Caption Health, MIM Software, icometrix, and Spectronic Medical).
- Next is Siemens Healthineers at 89 (including Varian), then Philips at 50 (including DiA Analysis and TomTec), Canon at 45 (including Vital Images and Olea), United Imaging at 38, Aidoc at 31, and DeepHealth at 28 (including Quibim and iCAD).
As we’ve noted in the past, the FDA’s list includes not only standalone software applications, but also imaging hardware with embedded AI applications, such as a mobile X-ray system with AI algorithms for detecting emergent conditions.
The Takeaway
The new FDA list shows radiology’s continued dominance when it comes to AI-enabled medical device technology. But an interesting subtext is the ongoing consolidation in the radiology AI space, which could mean that some firms may be climbing the list quickly.
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Empowering Radiologists at the Point of Interpretation
Rad AI and RSNA Ventures have partnered to deliver trusted, peer-reviewed RSNA insights directly into the radiologist’s workflow — at the exact point of interpretation. Watch this on-demand video to find out how it can benefit your practice.
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Enterprise Imaging Done Differently
Legacy radiology solutions were not designed to carry healthcare organizations into the future. From their first line of code, Mach7 Technologies was designed to meet the imaging needs of the entire healthcare enterprise. Learn more about their unique approach today.
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Meet with Visage at HIMSS 2026
Visage Imaging is not only leading imaging’s move to the cloud, they’ve defined it with their Visage 7 CloudPACS solution, which provides unparalleled speed and interpretation efficiency. Discover how Visage 7 can help you by booking a priority demo at HIMSS 2026 or drop by at booth #3753.
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- Sectra Highlights AI Open Standard at HIMSS: At this week’s HIMSS 2026, Sectra is demonstrating its progress toward developing solutions based on Model Context Protocol, an open standard for connecting AI applications to external systems that’s being developed across industries. Sectra is using MCP to power AI-driven actions and interfaces, enabling workflow automation for tasks like modality configuration and data analysis. At HIMSS, the company is highlighting an Operations AI prototype that’s powered by MCP.
- FDA Clears GE Viewer Software: GE HealthCare received FDA 510(k) clearance for View, a new zero-footprint diagnostic viewer that enables radiologists to interpret medical images from any location. View supports 2D and 3D visualization, and the application is the anchor of GE’s Genesis Radiology Workspace suite of cloud-based enterprise image management solutions that GE introduced at RSNA 2025. GE is highlighting the solutions at this week’s HIMSS 2026 conference.
- Visage Touts HIMSS Updates, Contract Renewals: Visage Imaging is highlighting new enhancements to its cloud-based enterprise imaging software at HIMSS 2026. New features in its 7.1.20 update include a new Visage 7 Web version, Visage Chat+, Visage 7 | Digital Pathology, and Visage 7 | AI, as well as AI-powered reporting. Visage also scored five-year contract renewals worth a total of $28M, one with MedStar Health in the Maryland/Washington, DC, area and the second with Long Island-based outpatient radiology provider Zwanger-Pesiri Radiology.
- Fujifilm’s HIMSS Highlights: Fujifilm Healthcare Americas has a number of enterprise imaging developments it is highlighting at HIMSS 2026. The company’s Synapse One image management software for outpatient facilities is being shown for the first time at HIMSS, and Synapse Worklist Orchestrator for load balancing and workflow orchestration is another highlight. Fujifilm is also touting Synapse AI Orchestrator, which supports easier deployment of multiple AI algorithms by bringing AI results directly into Synapse Enterprise PACS workflows.
- Predicting AI’s Value to Radiology: What’s the best way for radiology facilities to calculate return on investment when deploying radiology AI? Researchers from Radiology Partners in a new paper in AJR shared a system they used that was based on three pre-deployment criteria: 1) Reducing tedious tasks; 2) Limiting radiologist misses; and 3) Reducing the clinical impact of missed findings. They used the system to measure deployment of Aidoc algorithms for 12 clinical tasks in 88.6k exams, finding some applications were worth deploying while others needed more work.
- Philips Gets Cardiac MRI Software Clearance: The FDA cleared Philips’ SmartHeart software for planning cardiac MRI exams. Cardiac MRI is one of the most complex medical imaging exams due to the need to acquire multiple cardiac views, which has limited its adoption. SmartHeart automates 14 standard and advanced cardiac views in less than 30 seconds, enabling single-click CMR workflow. The solution’s AI engine was trained on 1.2k cardiac MRI datasets.
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- CT Use Grows in Elderly Patients: Elderly patients tend to be sicker, so it’s not surprising they get more medical care … including imaging. But a new study in BJR shows how quickly CT use for elderly patients is growing, and could be a cause for concern. Researchers analyzed CT use at a single hospital for patients aged 60-90 years, finding the proportion rose from 2014 to 2024 (from 50% to 58%), and is expected to hit 66% by 2035 – two-thirds of all CT scans.
- ASRT Selects New Officers: The American Society of Radiologic Technologists announced the results of its election to select new board officers for its 2026-2027 term. Shellie Pike of Radiology Consultants of Iowa was chosen as president-elect, while Emily Cash of Atrium Health Wake Forest Baptist in North Carolina was selected as vice president. Elected as secretary was James Reaves of Northside Riverdale Imaging in Atlanta, while Amanda Grocott of Sanford Medical Center Fargo in North Dakota was picked as treasurer. They start their terms in June.
- Ziosoft Touts On-Demand 3D at ECR: Advanced visualization software developer Ziosoft highlighted a new pay-per-use approach to 3D imaging at ECR 2026. The company’s ZioFlex subscription model gives users access to their Revoras advanced visualization tools without having to make a capital investment. Other ECR highlights included the company’s on-site CT coronary plaque analysis tool (pending FDA clearance) and support for cardiac MRI in Revoras’ cardiac suite.
- NXXIM Preps for Q2 Launch with Apollo Takeover: Enterprise imaging software developer NXXIM completed its takeover of Apollo Enterprise Imaging, laying the groundwork for a commercial launch in Q2 2026. NXXIM is developing what it calls a unified enterprise imaging intelligence platform that combines AI, vendor-neutral archive, multimodality data integration, and clinical decision support for multiple medical specialties, including radiology. Apollo is known for its arcc enterprise imaging software.
- Lack of Imaging Prompted Astronaut Return: New details have emerged around the return to Earth of a U.S. astronaut on the International Space Station. NASA said that Mike Finke experienced a medical event that required the use of advanced imaging that wasn’t available on the space station, and the entire crew was sent home with him in January. Finke’s condition has since stabilized. NASA has tested technologies like ultrasound and X-ray for use in space, but it’s not clear if those tools were available on Finke’s mission.
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Turning Clinical AI Research into Real-World Readiness
Discover how a strategic partnership between Stanford University and Radiology Partners’ Mosaic Clinical Technologies division will pioneer new methods for assessing and monitoring AI tools for medical imaging.
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Book a Meeting with Enlitic at HIMSS 2026
Enlitic empowers healthcare systems to leverage AI to enhance the quality of their medical imaging data. Learn how they can help make your data work for you by booking at meeting at HIMSS 2026, or visit them at booth #5337.
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