Tag: imaging AI

FDA AI Approvals Surge Past 1k for Radiology

Posted on by Brian Casey

The number of AI-enabled medical devices granted FDA marketing authorization for radiology surged past the 1k mark in the latest update from the agency. The numbers show that radiology’s share of authorizations remains stable at just over three-quarters of total approvals.

The FDA regularly releases the list in what’s become a closely watched barometer of both total approvals as well as which medical specialties are most active in AI.

  • Radiology has historically garnered the lion’s share of approvals – perhaps no surprise given the discipline’s early adoption of both digital image management and AI – with the first authorization granted in 1998 (for ImageChecker mammography CAD from R2 Technology/Hologic). 

The new list tracks authorizations through the end of September 2025, and indicates the agency has…

  • Authorized 1,356 AI-enabled devices since it started tracking, up 8.5% since its last report.
  • Approved 1,039 AI-enabled radiology devices, with imaging accounting for 77% of total medical authorizations since 1998.
  • Radiology secured 75% of total authorizations from June to September (83/110), compared to 78% from January to May 2025, 73% for all of 2024, and 80% for 2023. 
  • GE HealthCare retains the top spot as the company with the most radiology AI authorizations, at 110 (including recent acquisitions Caption Health, MIM Software, and icometrix).
  • Next is Siemens Healthineers at 86 (including Varian), then Philips at 48 (including DiA Analysis and TomTec), Canon at 41 (including Vital Images and Olea), United Imaging at 38, and Aidoc at 30. 

As always, it’s worth noting that the FDA’s list includes not only standalone software applications, but also imaging equipment that might have AI applications embedded into it, such as a mobile X-ray system with AI algorithms for detecting emergent conditions. 

  • Also, the agency noted that it is exploring ways to identify and tag AI-based devices that use foundation models and large language models. The FDA has yet to approve an LLM-based medical device.

The Takeaway

The new numbers indicate that radiology’s dominance of medical AI continues. But they also show that the FDA has returned to a regular twice-yearly cadence of updating its list of AI-enabled medical devices after a break of nearly a year – news that’s welcome to AI developers.

RSNA 2025 Video Highlights

Posted on by Brian Casey

RSNA 2025 is a wrap, and this year’s meeting offers an intriguing look at the forces that are shaping radiology – especially AI and imaging informatics.

It’s no secret that AI has come to dominate recent RSNA conferences, with its promise of fundamentally reshaping how radiologists do their jobs.

  • The hope is that by making radiologists more efficient, AI will help radiologists manage rising imaging volumes with a workforce that’s been largely stagnant.

But that dream has been a long time in coming, and the AI sector is being forced to make adjustments as it waits for broader clinical adoption. Many of these trends were on display at RSNA 2025, including…

  • Industry consolidation as AI developers make acquisitions to build out integrated suites of AI algorithms.
  • New questions about the commercial viability of the AI platform model given Bayer’s step back from Blackford.
  • The rise of AI network alliances as alternatives to the integrated suite or platform approaches.
  • Building excitement over the performance of foundation and vision language models for clinical tasks.
  • Renewed attention on radiology reporting as perhaps the primary use case where AI can truly help radiologists work more efficiently. 

Our video interviews from RSNA 2025 explore many of these topics and more, giving you an as-it-happened look at news from McCormick Place.

The Takeaway

We hope you enjoy watching our coverage as much as we enjoyed producing it! Check out the links below, on our YouTube page, or visit the Shows page on our website.

RP Acquires Vision AI Firm Cognita Imaging

Posted on by Brian Casey

Radiology Partners ramped up its investment in AI by acquiring Cognita Imaging, a startup that’s developed AI vision language models for analyzing CT and X-ray images and drafting initial radiology reports. RP executives see the acquisition as going beyond traditional point-source AI models and toward a future where AI automates much of the traditional image interpretation process.

The $80M acquisition expands on an equity stake RP already had in Cognita, which had been operating in stealth mode since its spin-off from Stanford University’s Center for Artificial Intelligence in Medicine and Imaging lab.

  • Cognita was formed by a team led by CEO Louis Blankemeier, PhD, to commercialize Stanford research on vision language models, a type of generative AI that’s far more versatile than the traditional point-source models being commercialized to analyze medical images.

Instead, Cognita’s technology is able to analyze text as well as CT or X-ray images and produce first drafts of radiology reports that just need a radiologist’s review and signature to be complete.

  • Extremely positive clinical tests with Cognita’s VLM models spurred RP to acquire the rest of the company it didn’t already own, said Rich Whitney, chairman and CEO of Radiology Partners. 

Cognita’s technology powers Mosaic Drafting, RP’s new application for helping radiologists draft reports that operates under the company’s recently launched Mosaic Clinical Technologies branding. Early clinical testing has found that Mosaic Drafting…

  • Increases radiologist detection rates by 52%.
  • Results in a fourfold decline in radiologist errors.
  • Reduces radiologist reading times by up to 76%.

RP plans to deploy Mosaic Drafting through Mosaic Clinical Technologies, which the company launched in July as the technological foundation for a massive rollout of AI across its physician practices. 

  • Mosaic Chief Medical AI Officer Nina Kottler, MD, said Mosaic Drafting is currently being used within Radiology Partners under IRB approval, but the company will pursue an FDA authorization – most likely under a de novo pathway – that probably will come sometime in 2026.

In a broader sense, RP sees Mosaic Drafting and other VLM tools as key to the growing mismatch between rising imaging volume and stagnant radiologist supply – a mismatch that can only be solved through greater automation. 

  • And as the largest private radiology organization in the U.S., Radiology Partners has the organizational heft to make VLMs work on a wide scale.

The Takeaway 

RP’s acquisition of Cognita is a major development in putting vision language models on the fast track to real-world clinical use. Unlike point-source AI, VLMs could hold the key to really solving radiology’s volume overload dilemma.

AI in Radiology: Old Problems, New Tech

Posted on by Partner Content

By Mo Abdolell, CEO, Densitas

Radiology has seen this movie before. Big promises (efficiency, accuracy, burnout relief). Big anxieties (ROI, workflow chaos, pressure to “keep up”). The question isn’t whether AI is powerful. It’s whether we’ve learned how to deploy new technology without repeating the pain of PACS migrations and the EHR era.

The Myth of the Perfect Rollout. Health technology assessment (HTA) sounds great in theory – rigorous, comprehensive, evidence-first. In practice, few organizations have the time, talent, or budget to execute it at scale. 

  • Remember EHRs: adoption happened because policy and money forced it, not because the playbook was tidy. Healthcare’s default pattern is to adopt, then evolve – messy, market-driven, and iterative. Waiting for perfect plans is how you get left behind.

Are AI’s Problems really new?

  • Black box déjà vu. Radiology has long trusted complex, opaque systems (reconstruction algorithms, vendor-specific pipelines). What mattered – and still matters – is validated performance and dependable outputs, not full internal transparency.
  • Model drift ≈ old friends. We’ve always recalibrated clinical tools as populations and scanners change. Monitoring and revalidation are known problems, not alien ones.

What’s Different This Time? Unlike the top-down EHR mandate, AI is largely market-driven. That gives providers agency. 

  • AI solutions must save time, improve outcomes, or avoid costs – not just publish a ROC curve. They must show operational value inside the native radiology workflow.

Fortunately, there are ways to adopt AI and then evolve your processes to make it work…

  • Workflow or bust. Demand in-viewer evidence objects, one-click report insertion, and EHR write-back. If AI adds steps, it subtracts value.
  • Start narrow, scale deliberately. Pick high-volume, high-friction tasks. Prove value in weeks, not years. Expand only when the operational signal is undeniable.
  • Measure what matters. Track operational metrics like seconds saved and coverage (e.g. eligible cases processed before dictation), reliability (e.g. results present before finalization, fail-open behavior), and user friction like context-switching rate and time-to-evidence.
  • Monitor. Stand up organization and site-level performance checks. Treat AI like equipment – scheduled, observed, and maintained.
  • Invest in long-term value. Favor standards, vendor-agnostic interoperability, clear telemetry, and transparent pricing.

The Takeaway

AI’s success in radiology won’t be defined by elegance of algorithms but by pragmatism of deployment. This will be an evolution – hands-on, incremental, sometimes messy. The difference now is that radiology can drive. Make the technology serve the service line – not the other way around.

Target the toughest workflows. Adapt and evolve with Densitas Breast Imaging AI Suite.

Could States Take Over AI Regulation from the FDA?

Posted on by Brian Casey

Could states take over AI regulation from the FDA as a possible solution to the growing workforce shortage in radiology? It may seem like a wild idea at first, but it’s a question proposed in a special edition of Academic Radiology focusing on radiology and the law. 

Healthcare’s workforce shortage is no secret, and in radiology it’s manifested itself with tight supplies of both radiologists and radiologic technologists. 

  • AI has been touted as a potential solution to lighten the workload, such as by triaging images mostly likely to be normal from requiring immediate radiologist review. 

And autonomous AI – algorithms that operate without human oversight – are already nibbling at radiology’s fringes, with at least one company claiming its solution can produce full radiology reports without human intervention.

  • But the FDA is notoriously conservative when it comes to authorizing new technologies, and AI is no exception. So what’s to stop a state facing a severe radiologist shortage from adopting autonomous AI on its own to help out? 

The new article reviews the legal landscape behind both constitutional and state law, finding examples in which some states have successfully defied federal regulation – such as by legalizing marijuana use – if the issue has broad public support. 

But the authors eventually answer their own question in the negative, stating that it’s not likely states will usurp the FDA’s role regulating AI because…

  • The U.S. Constitution’s Supremacy and Commerce clauses ensure federal law will always supersede state law.
  • If AI made an error, malpractice regulation would be murky given a lack of legal precedent at the state level. 
  • Teleradiologists could opt out of providing care to a state if AI regulations were too burdensome – which could exacerbate the workforce crisis. 

The Takeaway

Ultimately, it’s not likely states will take over AI regulation from the FDA, even if the healthcare workforce shortage worsens significantly. But the Academic Radiology article is an interesting thought experiment that – in an environment in which U.S. healthcare policies have already been turned upside down – may not be so unthinkable after all. 

Why Radiology Leaders Are Turning to AI – And Why They’re Not Looking Back

Posted on by Partner Content

From single-scanner clinics to university hospitals, radiology leaders around the globe face the same challenge: keeping up with rising patient demand while managing costs.

MRI volumes are climbing. Scanner hours and budgets? Not so much.

  • Under pressure to do more with less, decision-makers are reaching a conclusion that was unthinkable just a few years ago: AI-powered MRI is no longer a novelty – it’s a necessity.

No matter the size or scale of the operation, diagnostic imaging providers face a familiar set of challenges:

  • High capital costs – New scanners cost seven figures, and upgrades run hundreds of thousands.
  • Limited capacity – Most sites can’t easily add scanners, staff, or hours to meet demand.
  • Rising demand – MRI volume continues to grow as chronic conditions rise and preventive care gains traction.
  • Patient expectations – Long, uncomfortable exams frustrate patients who may look elsewhere.

AI offers a path forward, helping imaging teams handle more studies without compromising diagnostic standards.

AIRS Medical built SwiftMR, AI-powered MRI reconstruction software, to meet today’s imaging challenges. Hospitals and clinics in over 35 countries use SwiftMR to:

  • Reduce scan times by up to 50% compared to standard protocols.
  • Deliver sharper images radiologists can trust.
  • Enhance the patient experience with shorter exams and fewer motion-related rescans.

SwiftMR is vendor-neutral, compatible with all MRI makes, models, and field strengths.

FDA-cleared, MDR-certified, and clinically validated, SwiftMR is trusted by over 300 imaging providers in the U.S. and over 1,000 globally, including:

These outcomes show that AI-powered MRI delivers tangible operational, clinical, and financial benefits across site types and geographies. 

Watch this video to learn more about SwiftMR.

The Takeaway

Radiology leaders are relying on SwiftMR to transform how they deliver care. From enterprise networks to single-scanner clinics, imaging teams are unlocking new levels of efficiency and patient care.

RP Builds AI Mosaic as Company’s IT Foundation

Posted on by Brian Casey

Radiology Partners announced a new initiative to guide the rollout of AI across its nationwide network of radiology practices. The company’s new MosaicOS will be the IT foundation that connects RP practices and supports clinical uses from AI-assisted reporting to report generation and even image management.

Radiology Partners has grown since its founding in 2012 to become the largest privately held provider of imaging services in the U.S. and a major force behind the consolidation of private-practice radiology groups.

  • RP has always maintained a heavy technology investment, and has been looking closely at the rise of AI in radiology.

That’s because the growth in imaging volume is so massive that clinicians will no longer be able to care for patients adequately without AI’s assistance, at least according to RP’s Associate Chief Medical Officer for Clinical AI Nina Kottler, MD.

RP laid the groundwork for MosaicOS in 2020 by first migrating its technology stack to a cloud-native infrastructure. 

  • This frees RP from reliance on on-premises legacy software and enables the company to push out updates that can be adopted quickly across its network.

RP’s Mosaic rollout includes the following components as the company…

  • Forms a new division, Mosaic Clinical Technologies, to oversee its AI activities.
  • Debuts MosaicOS, a cloud-native operating system that combines AI support with workflow and other IT tools.
  • Launches Mosaic Reporting, an automated structured reporting solution that combines ambient voice AI with large language model technology.
  • Develops Mosaic Drafting, a multimodal AI foundation model that pre-drafts X-ray reports that radiologists can review, edit, and sign. 

Mosaic Reporting is already in use at some RP sites, and the company is pursuing FDA clearance for broader use of Mosaic Drafting. More Mosaic applications are on the way.

  • Mosaic tools will be disseminated to RP centers using the cloud-native infrastructure, and MosaicOS will include image management functions that providers can choose to use in place of or alongside existing tools like viewers and archives. 

Kottler told The Imaging Wire that RP has de-emphasized individual pixel-based AI models in favor of foundation models that have broader application.

  • What’s more, RP CEO Rich Whitney said the company has chosen to develop AI technology internally rather than rely on outside vendors, as this gives it greater control over its own AI adoption.

The Takeaway

The launch of MosaicOS marks an exciting milestone not only for Radiology Partners but also for radiology in general that could address nagging concerns about clinical AI adoption on a broad scale. RP has not only the network but also the technology resources to make the rollout a success – the question is whether outside AI developers will share in the rewards.

Radiology AI Approvals Near 1k in New FDA Update

Posted on by Brian Casey

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.

AI-Driven Lung Cancer Screening and Improving Patient Outcomes

Posted on by Partner Content

AI is reshaping clinical decision-making, optimizing resource allocation, and enhancing both patient outcomes and experience in CT lung cancer screening. Radiology providers are successfully integrating new AI software tools into hospital operations – supporting diagnostic accuracy and improving patient outcomes.

At the center of this trend is Coreline Soft’s FDA-cleared AVIEW LCS Plus, a 3-in-1 solution capable of detecting lung nodules, quantifying emphysema, and analyzing coronary artery calcification – all from a single low-dose CT scan. 

  • AVIEW LCS Plus is in use at Temple Health, a nationally recognized institution in the U.S. Northeast, where it has allowed providers to streamline clinical workflows from detection to follow-up, delivering measurable improvements in care and ROI.

Coreline Soft will co-host a strategic webinar with the Temple Lung Center on August 1 at 1:30 PM ET, focused on AI-powered lung cancer screening and the evolving paradigm of early detection for chest diseases.

The webinar will offer firsthand insight into how Temple Health is drawing attention as a model for integrating AI beyond diagnosis – transforming it into a scalable, patient-centered care strategy.

The discussion will focus on two main areas…

  • Real-world outcomes: How AI improved diagnostic efficiency, early detection, and comorbidity detection.
  • A deep dive into the precision technology of the AVIEW LCS Plus platform.

AI like Coreline’s is not replacing clinical judgment, but reinforcing it, enhancing radiologists’ ability to detect, triage, and treat lung disease earlier and more efficiently, Criner believes. 

  • The webinar is open to pulmonologists, radiologists, cardiologists, respiratory-adjacent professionals, hospital stakeholders and administrators, and primary care providers across the U.S. and Canada. Interested participants can register for free in advance via the official registration link. 

The Takeaway

AI solutions like Coreline Soft’s AVIEW LCS Plus platform are having a real-world impact on healthcare providers as they roll out CT lung cancer screening programs. Sign up to learn more on August 1.

AI and Legal Liability in Radiology

Posted on by Brian Casey

What impact will artificial intelligence have on the legal liability of the radiologists who use it? A new study in NEJM AI suggests that medical malpractice juries may pass harsher judgment on radiologists when they make mistakes that disagree with AI findings.

AI is viewed as a technology that can save radiologists time while also helping them make more accurate diagnoses.

  • But there’s a dark side to AI as well – what happens when AI findings aren’t correct, or when radiologists disagree with AI only to discover it was right all along?

In the new study, a research team led by Michael Bernstein, PhD, of Brown University queried 1.3k U.S. adults on their attitudes toward radiologists’ legal liability in two clinical use cases for AI – identifying brain bleeds and detecting lung cancers.

  • Participants were asked if they felt radiologists met their duty of care to patients across different scenarios, such as whether the AI and the radiologist agreed or disagreed on the original diagnosis. 

Responses were compared to a “no AI” control scenario in which respondents assessed legal liability if radiologists hadn’t used AI at all, with researchers finding …

  • If radiologists disagreed with AI, more respondents found radiologists liable …
    • Brain bleeds: 73% found radiologist liable (vs. 50% with no AI)
    • Lung cancer: 79% found radiologist liable (vs. 64% with no AI)
  • If both radiologists and AI missed the diagnosis, there was no statistically significant difference …
    • Brain bleeds: (50% vs. 56% with no AI, p=0.33)
    • Lung cancer: (64% vs. 65% with no AI, p=0.77)
  • Respondents were less likely to side with plaintiffs when given information about standard AI error rates …
    • When AI agreed with the radiologist diagnosis:
      • Brain bleeds: (73% plaintiff agreement fell to 49%)
      • Lung cancer: (79% fell to 73%)
    • When AI disagreed with the radiologist diagnosis:
      • Brain bleeds: (50% plaintiff agreement fell to 34%)
      • Lung cancer: (64% fell to 56%)

The Takeaway

The new study offers a fascinating look at AI’s future in radiology from a medico-legal perspective. But there’s one question the researchers didn’t address: If AI-supported image interpretation eventually becomes the standard of care, will radiologists be found liable for not using it at all? Stay tuned. 

Get every issue of The Imaging Wire, delivered right to your inbox.