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Top 10 AI Vendors, Mammo Patent Suit, and Biopsy Needle Shortage
June 18, 2026
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Together with
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“If AI makes radiologists more efficient, the price of their services doesn’t go down. The AI cost savings go back to the owners of the practice, not to the customer/patient/payer.”
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Curtis Langlotz, MD, PhD, of Stanford University.
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Major changes have occurred concerning Medicare reimbursement for AI-powered scoring of coronary artery calcium and aortic valve calcification, using code G0680. In this edition of The Imaging Wire Show, I talked to Allen Hundley of Riverain Technologies about the changes and how providers can now get paid for these important medical imaging exams. – Brian Casey, Managing Editor
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Who are the top 10 radiology AI vendors, based on the number of FDA regulatory authorizations? The agency provided some clarity this week with an update to its list of authorized AI-enabled medical devices through the end of Q1 2026.
The FDA updates the list on more or less a quarterly basis, and it’s become a closely watched barometer for tracking not only the health of the AI industry but also which companies have received the greatest number of authorizations.
- As we’ve noted in the past, the list includes both standalone AI algorithms as well as medical hardware that has AI functionality embedded in it, like a mobile X-ray machine with an onboard AI feature for detecting fractures.
The updated list tracks marketing authorizations through the end of March 2026, and shows that the FDA has…
- Authorized 1,524 AI-enabled medical devices since it began keeping track in 1995, up 5.1% from Q4 2025.
- Authorized a total of 1,164 radiology devices, or 76% of all AI-enabled medical authorizations.
- In the first quarter of 2026, the FDA authorized 92 AI-enabled medical devices, or 28% more than in the fourth quarter of 2025.
- For the quarter, 69 authorizations (75%) were for radiology devices, about the same ratio as in Q4 2025 (76%).
- GE HealthCare held its lead as the company with the most radiology AI authorizations at 130 (including recent acquisitions that had AI authorizations of their own).
- Next is Siemens Healthineers at 95, then Philips at 58, Canon at 48, United Imaging at 40, Aidoc at 33, and DeepHealth at 29, with all numbers including acquisitions.
- Rounding out the top 10 are Samsung (21), Rapid.ai (20), and Hyperfine (13).
The Takeaway
The FDA’s new numbers on AI marketing authorizations show that the agency is keeping pace with rapid developments in the healthcare AI industry. Indeed, the FDA is even accelerating its pace of product approvals compared to its last update, with radiology still securing the lion’s share of authorizations.
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- Hologic Wins European Patent Case: Hologic won a judgment in a European patent lawsuit against Siemens Healthineers over digital mammography technology. The EU’s Unified Patent Court ruled that Siemens infringed a Hologic breast imaging patent covering “controlling x-ray focal spot characteristics for tomosynthesis and mammography imaging,“ which Siemens marketed as a “flying focal spot.” The court not only barred Siemens from selling its Mammomat B.brilliant systems in Germany, France, and the Netherlands but also required installed systems to be destroyed. Siemens can appeal the decision.
- FDA Addresses Breast Needle Shortage: The FDA this week weighed in on the ongoing shortage of Hologic stereotactic breast biopsy needles. The company in January 2026 issued a recall of its 9-gauge Brevera needles due to plastic and metal particles getting dislodged during use. In its update, the FDA recommended that providers try to conserve needles they have in stock, diversify the vendors they work with, and use older needles when available. Shortages are expected to persist through Q1 2027.
- Lesion Conspicuity on CEM: With contrast-enhanced mammography images, is there a relationship between lesion conspicuity – how well a lesion shows up – and malignancy? Not necessarily, according to a new European Radiology study that found a trend that wasn’t statistically significant. In CEM exams of 455 women, positive predictive value for malignancy for low-, moderate-, and high-conspicuity lesions was 9%, 11%, and 10%, respectively (all p > 0.05). Most enhancing lesions – including most cancers – have low or moderate CEM conspicuity.
- Specimen PET/CT Improves Cancer Surgery: The use of a dedicated specimen PET/CT scanner to assess cancer margins improved success rates in women undergoing breast cancer surgery. In a paper in JAMA Surgery, specimen PET/CT with Xeos Medical’s AURA 10 scanner with submillimeter resolution was used in 148 women with early-stage breast cancer to find evidence of invasive cancer in surgical margins. The scanner improved success rates compared to either no margin assessment or conventional routine margin assessment (92% vs. 76% and 82%, respectively).
- AIRS Medical Secures PE Investment: AIRS Medical landed an investment from private equity firm TA Associates. The amount of the investment was not disclosed, but TA Associates is known to only invest above $150M in its portfolio companies and only work with profitable companies. AIRS will use the funds to fuel global expansion for its MRI acceleration and reconstruction software, which is used at over 1.7k healthcare institutions in over 40 countries.
- Eyeing Occupational Radiation Exposure: A new study in Physica Medica confirms that occupational radiation exposure for interventional radiology procedures is generally low and within international guidelines. Researchers from Finland analyzed dose to the eye lens and whole body for CT-guided procedures during four separate four-week monitoring periods at four hospitals. Doses were below occupational dose limits at all hospitals, although one facility had higher doses as it used fluoroscopy without a lead glass screen because radiologists had to stand close to patients to guide biopsy needles.
- Emory Migrates to Sectra One Cloud: In a first for Sectra in the U.S., Emory Healthcare has migrated its enterprise IT infrastructure to the company’s Sectra One Cloud solution. Emory is the largest healthcare provider in Georgia, operating 11 hospitals and over 250 provider locations. Emory has been a Sectra customer since 2021, and migrating its network to the cloud will reduce workload for its IT teams while ensuring high availability, performance, and secure operations.
- CMS Gets New Health Tech Office: CMS officially established a new office to focus on driving interoperability in healthcare technology, complete with eight divisions and 100 unique responsibilities. The U.S. Office of Health Technology and Products will provide enterprise leadership for CMS’ health tech strategy and “promote interoperability, open standards, and secure data exchange across CMS programs.” Although that job has typically fallen on the ONC, the new office might have better luck given that it can wield reimbursement to advance its agenda.
- Clinician AI Use Triples: Wolters Kluwer’s 2026 Future Ready Healthcare Report highlighted the shifting perspectives of both clinicians and patients around the evolving AI landscape. One of the more interesting findings was that only 27% of clinicians know their organization’s AI policy, up just 6 percentage points in a year, while their daily AI use has tripled. On the patient side, 42% report bringing AI-generated content into medical appointments, and 59% of clinicians say they engage with that information during visits. A vast majority of clinicians (77%) are worried about erosion of clinical decision-making skills, and 68% of patients share concerns around clinician overreliance on AI.
- Healthcare Costs to Spike in 2027: PwC expects medical costs to climb another 9% in 2027, the highest jump in 17 years. The firm’s latest estimates have spending on track to top $9T (yes, that’s a T for trillion) by 2035, driven primarily by pharmaceutical innovation, mental healthcare, and growing provider reimbursement pressure combined with the adoption of AI-enabled revenue optimization tools. “Without macro health cost deflators, payers and employers face mounting pressure to act.”
- Cardiac Remodeling and Cancer Risk: A new JAHA analysis suggests that small changes in the heart over time may signal an increased risk of certain cancers. Reviewing cardiac MRI data from 4.5k patients in the MESA study, researchers found that patients with increased heart muscle mass were more likely to go on to develop breast cancer. Reduced left atrial function was also linked to a greater risk of developing colorectal cancer. While this doesn’t mean that cardiac remodeling causes cancer, it does highlight the potential value of cardiac measurements for cancer detection.
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Leveraging AI-Powered Discovery for Image Exchange
Southwest Medical Imaging, a premier physician-owned radiology practice in the southwestern U.S., partnered with Medicom to streamline their workflow. Discover how SMIL utilized Medicom’s AI-powered Smart Search, which leverages an LLM to automatically detect and surface imaging data, to eliminate manual searching and accelerate patient care.
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- New Tools for Detecting Cardiovascular Plaque: New imaging tools are advancing the detection of cardiovascular plaque – a key risk factor for heart attack. In this video, ClearCardio’s John Osborne, MD, PhD, discusses these innovations, including United Imaging’s uCT ATLAS CT scanner and their Software Upgrades for Life program.
- Reporting Shouldn’t Feel Like a Chore: Rad AI Reporting practically reads your mind, instantly translating complex scans into meaningful analysis. Learn more about the intuitive co-pilot your workflow has been waiting for. Book a demo.
- One Viewer for All: Achieve ultrafast image interpretation with greater efficiency and precision with Visage 7 from Visage Imaging. Visage’s one-viewer philosophy enables all end users – from radiologists to clinicians – to access powerful tools based on clinical need.
- AI-Assisted Radiology Reporting: Move beyond legacy radiology reporting with AI-assisted reporting from Mosaic Technologies. See how Mosaic Reporting can help your organization move faster today while building for tomorrow.
- How AI Is Redefining Data Migration: Enlitic’s Migratek data migration services – combined with AI-enabled ENDEX data standardization – is changing the game for data migration projects. Discover how it can benefit you in this article.
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- Accelerating Care Today for More Tomorrows: GE HealthCare empowers precision care with innovative imaging, patient management solutions, and tailored consulting services for every step of the theranostics pathway. Learn more about theranostics on this page from GE HealthCare.
- Fewer Biopsies, Better Accuracy: AI is converging with TI-RADS and BI-RADS in ways that go beyond automation. Read this article from Kailo Medical to learn how structured reporting is reducing unnecessary biopsies, improving consistency, and reclaiming clinical time.
- Opportunistic Detection of CAC and Pulmonary Nodules: Achieve a newfound certainty of search for thoracic CT when using ClearRead CT from Riverain Technologies. It’s a natural addition for opportunistic CAC scoring and nodule detection, or as part of a CT lung cancer screening program.
- Accelerate Enterprise Imaging in the Cloud: It’s more than a traditional VNA. Discover how Merge Imaging Suite VNA v26.0 provides robust vendor-neutral image archiving with the scalability and security of Microsoft Azure.
- Bringing Real-Time AI Echo to Clinicians: Us2.ai and deepc are bringing real-time standardized AI echo analysis and reporting to clinicians through their new partnership. Find out how Us2.ai’s software is now available within the deepcOS platform.
- A Best in KLAS Hat Trick: AGFA HealthCare was named Best in KLAS in three enterprise imaging segments this year: PACS under 300k studies, universal viewer, and vendor-neutral archive. Find out what makes customers keep coming back on this page.
- Experience Dynamic Simplicity in Fluoroscopy: Still on the fence about upgrading to the latest technology that fluoroscopy has to offer? Hear from your peers about their experiences with the first-ever installed LUMINOS Q.namix R system from Siemens Healthineers.
- Curiosity, Growth, and the Joys of Radiology: What makes a great radiologist? The residency program? The fellowship pedigree? The hospital name on the badge? Check out the inaugural episode of Medality’s The Joys of Radiology podcast, featuring a conversation between Marc Gosselin, MD, and Gautam Agarwal, MD.
- Remote Reading Is Essential for Enterprise Imaging: Remote reading has become essential to enterprise imaging operations because healthcare organizations need scalable, flexible solutions. Discover how cloud-based solutions from Intelerad can help solve remote reading challenges.
- Adding AI Automation to Radiology Reporting: Reporting Pro from DeepHealth is a next-generation AI-powered solution designed to transform the way radiologists generate clinical reports and findings. Discover how it can transform your practice.
- Preserve Your Radiography Investment: FutureProof 20 is Philips’ commitment to support their Radiography 7300 C for 20 years, helping you keep the system performing for decades, reducing total cost of ownership over the long run and letting you focus on the patient.
- Radiology Case Report: A man in his 50s presented with syncope with minor head trauma and unassociated risk factors. Find out how MRI helped provide a diagnosis in this case study.
- IT Solutions for Radiologist Efficiency: Inefficiencies in reporting are some of the biggest challenges facing radiologists today. Learn how imaging IT solutions from Altamont Software can help radiologists work more efficiently in this Imaging Wire Show video.
- Don’t Leave Your Patients in the Dark: See how top health systems like Duke Health, and Lumexa Imaging are using patient-friendly radiology reports from Scanslated to boost patient engagement and satisfaction.
- Built for Today’s Demanding ORs: The Persona C HR mobile C-arm from Fujifilm Healthcare Americas combines high-power performance, ultra-low-dose imaging, and surgeon-friendly control – all in a lightweight, spacious design. Discover its advantages today.
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