Vara received CE mark under EU MDR (Class IIb) for its tomosynthesis AI in June 2026. The approval extends a portfolio that already covers full-field digital mammography as concurrent and independent second reader — and it arrives at a moment when tomosynthesis is moving from the evidence base into procurement specifications across European screening programmes.

Since the publication of PRAIM in Nature Medicine in 2025, Vara has received CE for independent second reading, launched the three-prior model commercially, and extended reach to 10+ European countries through distribution partnerships with DeepC, Sectra Amplifier, Quibim, and Medical Horizons. In Germany, Vara now supports 60% of the organised screening programme — more than 250,000 screenings per month.

Tomosynthesis is the next step in that trajectory. The TOSYMA trial, published in The Lancet Oncology, showed DBT detects invasive cancers at a 48% higher rate than standard mammography. What makes adoption operationally complex is the workload. A two-view tomosynthesis acquisition produces hundreds of reconstructed slices where standard mammography produces four images. In a screening environment already under pressure from radiologist shortages, programmes want the detection benefit but cannot always absorb the reading volume.

Vara’s tomosynthesis model is designed around that constraint. It sits inside existing PACS workflows without adding steps for the radiologist, and programmes already running Vara for standard mammography can extend to tomosynthesis within the same integration. Breast cancer risk prediction follows on the roadmap — moving from case-level reading support to longitudinal monitoring that identifies women at elevated risk before a cancer is detectable.

Vara will be at the Senologiekongress in Munich from 11 until 13 June with a live demonstration. Further information at vara.ai.

Scaling AI across a screening program is not a science problem. The evidence is in. It is an infrastructure problem. The screening programs that will adopt AI successfully are the ones where the platform, the workflow, and the AI already speak the same language.

Vara is now available on the Sectra Amplifier Marketplace. Sectra customers can access Vara’s mammography AI directly from the existing Sectra diagnostic application, with a seamless, integrated user experience and no change to their workflow.

Sectra is the enterprise imaging platform behind 2,500+ installations across 60 countries, managing 170 million imaging exams per year. It has ranked #1 in customer satisfaction in enterprise imaging for 12 consecutive years. For screening programs and hospital networks already on Sectra, Vara is now accessible within the platform they use every day.

Why this is an infrastructure problem

European screening programs are not short on evidence that AI works. The PRAIM study, published in Nature Medicine, demonstrated +17.6% cancer detection, up to -15% false recalls, and -59% radiologist workload reduction across 463,156 women in Germany’s national program. Italy’s Istituto Superiore di Sanità issued Europe’s first national guideline recommending AI triage in organized mammography screening in January 2026. The EU now recommends AI-supported double reading over double reading without AI. The UK just launched EDITH, an £11 million trial across 30 sites and 700,000 women.

What programs are short on is a clear path from “we want AI” to “AI is running in our screening workflow.” Every additional system, every new viewer, every separate IT contract between the decision and the deployment is friction. And in screening, where 45% of European radiologists are over 51 and demand is rising, friction is measured in years of delayed adoption and missed cancers.

That is what the Sectra Amplifier Marketplace is designed to solve: accelerating the adoption of AI into clinical practice by making applications accessible within the existing Sectra diagnostic workflow. Vara now lives inside that workflow. No separate integration project. No new viewer for radiologists to learn.

What Vara brings

Vara is the specialist AI for large-scale screening deployments. We currently support approximately 50% of Germany’s national breast cancer screening programme, processing around 200,000 cases per month across seven years of continuous, cloud-native deployment. It is the largest AI deployment in any organized screening program worldwide.

The clinical foundation is the PRAIM study: the world’s largest and only nationwide prospective trial in mammography AI. 12 centres, 119 radiologists, 463,156 women, routine clinical conditions, all major scanner types (Fuji, GE, Giotto, Hologic, Siemens), zero exclusion criteria. Optimising for one outcome at the expense of another is the more common finding in the literature; PRAIM showed detection, recall, and workload all improving at the same time.

Vara is also the only AI CE-marked for independent second reading in mammography. Through the Sectra Amplifier Marketplace, Sectra customers now have access to both concurrent and independent AI for mammography, from triage to full second reader replacement, backed by leading performance on priors. An independent evaluation at Karolinska across 10,348 screening participants showed Vara’s positive predictive value reaching 18.0% with three rounds of priors, above the radiologist benchmark of 10.1% and a result no other vendor matched.

And every deployment comes with real-time monitoring across six clinical safety dimensions, the operational backbone that proves AI keeps performing in the real world, not just during a controlled study.

Why Sectra

Sectra is not just any PACS. It is the imaging backbone behind some of Europe’s largest screening programs. In the Netherlands, Sectra runs the entire national breast screening program: 59 mobile trailers, 11 fixed screening locations, and 29 reading units serving 2.2 million eligible women. In Sweden, Region Skåne uses Sectra with integrated AI for breast screening. In the UK, Sectra is the leading enterprise imaging provider by market share. Across 60 countries, Sectra manages 170 million imaging exams annually.

Sectra has been investing heavily in its AI infrastructure. Earlier this year, it completed the acquisition of Oxipit, the Lithuanian AI company behind ChestLink (the world’s first CE Class IIb certified autonomous AI for chest X-ray analysis). Its Amplifier Marketplace already hosts over 100 AI applications. And at HIMSS 2026, Sectra showcased Model Context Protocol (MCP)-powered prototypes designed to make AI integration across enterprise imaging seamless and interoperable.

For radiologists who already live inside Sectra’s diagnostic viewer every day, Vara does not mean learning a new system. It means their existing system gets smarter.

Why this matters now

Europe’s screening programs face growing case volumes, radiologist capacity under pressure (nine EU countries will lose a higher share to retirement by 2027 than the EU average), and screening age ranges expanding to cover women 45 to 74. Countries are rewriting guidelines. Italy issued Europe’s first national recommendation for AI triage in screening. The UK launched an £11 million trial across 30 sites. The EU committed €1 billion through Apply AI Strategy. The question is no longer whether AI belongs in screening. It is how fast programs can get it running inside the systems their radiologists already use.

Vara being available on the Sectra Amplifier Marketplace is built for exactly that scale. The programs that move now will be the ones that chose their infrastructure wisely.

Vara, based in Berlin, and Quibim, headquartered in Valencia, are announcing a partnership to make Vara’s mammography AI available across Spanish breast cancer screening programs.

The pressure on Spanish screening

Across Europe, organized screening is working against three forces at once: a shrinking pool of breast radiologists, expanding eligibility criteria that pull more women into the program every year, and the rising financial weight of double reading on already-stretched budgets. Spain sits squarely inside that picture.

Programs cannot resolve any of this through hiring alone. The supply of specialists trained in mammography is not growing fast enough to match demand, and the cost curve of running double reading at scale keeps moving in one direction. AI-supported reading is one of the few options that touches capacity, recall rates, and cost in the same intervention, assuming the evidence behind it is solid.

Why Vara

Vara is purpose-built for mammography. We currently run in roughly half of Germany’s national breast cancer screening program, with around 200,000 cases per month and seven years of continuous clinical deployment behind us. That makes it the largest AI deployment inside any organized breast cancer screening program in the world.

Our PRAIM study, published in Nature Medicine, is the largest prospective evaluation of AI in screening conducted to date: 463,156 women, 12 centers, 119 radiologists, all under routine clinical conditions. The result was a 17.6% increase in cancer detection alongside a reduction in unnecessary recalls, with radiologist workload falling by up to 59% across the cohort. No other landmark trial in mammography AI has shown higher detection and lower recall rates in the same study population.

The infrastructure underneath those numbers matters as much as the numbers themselves. Every program we work with gets clean integration with existing PACS and reporting environments, plus continuous real-time monitoring of how the AI is actually performing in production. In screening, that kind of ongoing oversight is what separates a credible deployment from a press release.

Why Quibim

Quibim has spent more than a decade building clinical-grade AI for radiology. The team has deep roots across Spanish hospital systems and academic radiology, and a consistent record of choosing evidence over speculative claims, which is the only foundation a screening partnership can credibly start from.

For Spanish programs adopting Vara, Quibim provides direct presence on the ground, fluency in the Spanish regulatory and procurement environment, and an existing network of radiology leaders who will be among the first to evaluate AI inside their screening workflows.

A particular thank you to Ángel Alberich-Bayarri and the wider Quibim team for the partnership and the work ahead.

Why this matters

Spanish screening programs do not have the luxury of a multi-year evaluation cycle. The radiologist supply is what it is; eligibility keeps expanding; the budget pressure on double reading is already on the table. The practical question for program leaders is which AI has enough real-world evidence and operational maturity to be trusted inside an organized screening pathway, and which partner can actually get it deployed across Spanish institutions.

Vara and Quibim bring both halves of that answer: the largest body of prospective evidence in mammography AI, paired with a Spanish partner whose reputation in clinical radiology is already established. The aim is concrete, more effective and more sustainable screening, for the radiologists running these programs and for every woman who walks into a screening unit in Spain.

Vara, headquartered in Berlin, and Medical Horizons, Italy’s leading distributor of AI-based medical devices, are announcing a partnership that brings Vara’s screening AI to Italian mammography programs at a defining moment for the country.

Italy’s landmark moment

In December 2025, Italy’s National Institute of Health (Istituto Superiore di Sanità) issued updated national guidelines formally recommending AI as a triage tool within organized mammography screening. With this, Italy became the first European country to issue a national-level conditional recommendation in favor of AI-based triage to determine whether mammograms require single or double human reading.

It is a landmark moment for evidence-based AI in radiology, and it shifts the question from whether AI belongs in screening to how well it gets deployed.

What Vara is built for

Vara is designed for mammography, screening and diagnostic. We currently support approximately 50% of Germany’s national breast cancer screening programme, processing around 200,000 cases per month across seven years of continuous deployment. It is the largest AI deployment in any organized screening program worldwide.

The clinical evidence comes from the PRAIM study, published in Nature Medicine in January 2025: 12 centres, 119 radiologists, 463,156 women, routine clinical conditions. +17.6% cancer detection, up to -15% false recalls, -59% radiologist workload reduction. All across major scanner types, with zero exclusion criteria. Optimising for one outcome at the expense of another is the more common finding in the literature; PRAIM showed all three improving at the same time.

Beyond evidence, what Vara brings to every program is seamless IT integration and continuous real-time AI performance monitoring, the operational backbone that lets screening programs adopt AI without compromising on patient safety.

What Medical Horizons adds

Medical Horizons has over 30 years of experience working across Italian healthcare institutions, including Campus Bio-Medico University Hospital in Rome. The team has deep relationships with the regional health authorities and screening organizations that will be moving the new national guidelines from recommendation to clinical practice.

For Italian programs that want to adopt Vara, Medical Horizons provides the local presence, regulatory familiarity, and clinical network needed to deploy AI responsibly at scale.

Why this matters

Italy’s screening programs are now in the early window between guideline and implementation. The decisions made in this period (which AI, which deployment model, which evidence base) will shape how AI is used in Italian breast cancer screening for years to come.

The case for AI in screening rests on real-world evidence at scale, not pilot studies or marketing claims. Italy has set a high bar by anchoring its recommendation in clinical evidence. The partnership between Vara and Medical Horizons is built to meet that bar: bringing the largest body of prospective real-world evidence in mammography AI into Italian screening through a partner who knows the system from the inside.

Italy has set the European standard. We are honored to help answer the question of how well AI gets deployed alongside Medical Horizons and Italy’s screening community.

Vara, headquartered in Berlin, and deepc, based in Munich, are two of Germany’s most recognised names in AI radiology. Today, we are announcing a partnership that makes Vara available to more screening programmes and diagnostic centres across Europe through the deepcOS® platform.

What Vara is built for

Vara is designed for mammography, screening and diagnostic. We currently support approximately 50% of Germany’s national screening programme, processing around 200,000 cases per month across seven years of continuous deployment.

The clinical evidence comes from the PRAIM study, published in Nature Medicine in January 2025: 12 centres, 460,000 women, routine clinical conditions. +17.6% cancer detection, -43% reading time, -56.7% radiologist workload reduction, all three improving at the same time. Optimising for one at the expense of another is the more common finding in the literature. Since publication, continued development has exceeded even those benchmarks.

What sets Vara apart in that evidence base is how it performs with prior imaging. An independent evaluation across 10,348 screening participants in Sweden compared commercially available AI vendors on positive predictive value. Without priors, Vara scored 9.3%. With one prior, 11.4%. With three priors, 18.0%—above the radiologist benchmark of 10.1%, and a result no other vendor in the evaluation matched or supported. The ability to use multiple priors is a technical capability most competitors do not offer.

What deepc adds

deepcOS® is vendor-neutral AI deployment infrastructure operating across 30+ countries. It handles the integration complexity that makes scaling AI across heterogeneous clinical and IT environments difficult: different PACS systems, different workflows, different regulatory contexts.

For programmes and providers that want to adopt Vara, deepcOS® provides an additional path into existing clinical environments with no change to how radiologists work.

Why this matters

For most programmes, the remaining question is practical: how do we access this, and how do we integrate it without a multi-year IT project. The deepcOS® partnership extends Vara’s reach to providers across Europe who want evidence-based AI for mammography without the integration overhead.

Europe’s screening programmes face growing case volumes, radiologist capacity under pressure, and the need to improve detection without increasing recall rates. The evidence that AI addresses all three exists. Friction in access and integration has slowed adoption. The deepcOS® partnership addresses that directly, extending Vara’s reach to providers across Europe who want evidence-based mammography AI through infrastructure they may already use.

Until now, there has been no AI on the market authrised to do what a second radiologist does — read a mammogram independently.

That changed on 15 October 2025. Vara received a new CE certificate for its breast-imaging AI. It is the only AI on the market authorised to operate as an independent second reader, for both screening and diagnostic use. It marks Vara’s entry into the European market.

Why independent reading matters

Most AI in breast screening operates as decision support — a tool that highlights findings for a radiologist to review. An independent second read is fundamentally different. The AI reads the mammogram on its own, the same way a second radiologist would.

This matters because maintaining a human second read is often not economically feasible, particularly in diagnostic workflows. Many programmes simply can’t staff it. An AI that is authorised and clinically validated for that role fills a gap that has been widening for years.

The evidence behind it

This CE mark didn’t happen in a vacuum.

Earlier this year, Nature Medicine published the PRAIM study — initiated by Vara and conducted across 12 screening centres in Germany. It enrolled 460,000 women with no exclusion criteria, making it the largest prospective, real-world study of AI in healthcare.

The results: statistically significant superiority in cancer detection rate and meaningful workload reduction for radiologists.

PRAIM is what made approval for independent second reading possible. Not a retrospective analysis. Not a single-site pilot. A population-wide, prospective study across a national programme.

What regulators recognised beyond performance

In approving Vara’s AI for independent second reading, regulators also recognised something else: Vara’s autonomous, prospective AI monitoring system.

This is the real-time quality assurance infrastructure we’ve written about before — continuous, case-level monitoring of every AI prediction, connected to clinical outcomes. Regulators saw it as setting a new standard for responsible deployment.

Evidence gets you approved. Monitoring is what makes deployment safe.

What’s available, and where

The CE-marked product is available in Europe starting today, as an independent second read or decision support system — including analysis of mammograms from prior screening rounds.

Providers can integrate Vara directly in their PACS viewer, or via the Vara platform. That platform currently serves 40% of the German national screening programme, processing approximately 150,000 mammograms monthly and more than 1.5 million annually.

What this means going forward

Stefan Bunk, co-founder and CTO of Vara:

“Our ambition has always been to pioneer data-driven AI at a nationwide scale. The industry has long moved beyond retrospective evidence. Now, by pairing population-wide, real-world results with automatic real-time monitoring, we’re offering a credible, scalable path for AI in healthcare.”

Europe’s screening capacity challenge isn’t theoretical. It’s here. The question is whether AI can meet the clinical, regulatory, and operational bar required to help.

With the largest prospective evidence base in healthcare AI, the only CE mark for independent second reading, and real-time monitoring built into every deployment — Vara’s answer is yes.

Vara builds AI and cloud workflow tools for breast imaging, helping radiologists detect cancer earlier while reducing unnecessary recalls and reading time

For years, the case for AI in radiology rested on retrospective data and small, controlled settings. That changed on 7 January 2025, when Nature Medicine published the PRAIM study — the first nationwide deployment of AI in Germany’s National Screening Program.

PRAIM enrolled 500,000 participants across Germany. It was conducted by Vara and the University of Lübeck. It is the largest prospective, real-world study of AI in healthcare to date.

What PRAIM measured

The study integrated AI into live screening workflows and tracked what happened to two things: cancer detection and radiologist workload.

The findings:

• AI integration improved cancer detection rates by 17.6%, without increasing false positives

• Radiologists spent 43% less time interpreting AI-tagged normal examinations

• In a simulated scenario where radiologists did not interpret AI-labelled normal mammograms — 56.7% of all scans — cancer detection rate still improved by 16.7%, while recalls fell by 15%

These are not lab results. They come from a live national screening programme, across multiple centres, with no exclusion criteria.

Why this study is different

Previous AI studies in radiology have typically relied on retrospective datasets or controlled research environments. PRAIM was prospective and deployed in routine clinical practice — the same conditions under which AI would need to perform if adopted at scale.

That distinction matters. Retrospective studies can show that AI performs well on historical data. Prospective studies show whether it performs well when radiologists actually use it, in real workflows, on real patients.

Professor Alexander Katalinic, Head of the Institute of Social Medicine and Epidemiology at the University of Lübeck and lead investigator:

“The results are extremely positive and have exceeded our expectations. We can now demonstrate that AI significantly improves the cancer detection rate in screening for breast cancer.”

What this means in practice

Germany screens millions of women annually. If PRAIM’s results were applied across the full programme, the implications are straightforward: more cancers caught earlier, fewer unnecessary recalls, and a meaningful reduction in the reading workload that screening programmes are struggling to staff.

The 56.7% workload finding is particularly relevant. More than half of all scans were AI-labelled normal — and even without a radiologist reviewing those, detection rates still improved. For programmes facing chronic radiologist shortages, that is not a theoretical efficiency gain. It is a practical path forward.

Context

Vara’s AI is integrated into 40% of Germany’s national screening centres, processing over 80,000 mammograms monthly. The company has published in Nature Medicine and Lancet Digital Health, and holds what is now the largest prospective evidence base for AI in any radiology specialty.

Stefan Bunk, CTO of Vara:

“The PRAIM study is a testament to the vast potential of AI in improving breast cancer screening. We are confident that the results will elevate the discussion about AI-assisted mammography screening, paving the way for wider adoption in health systems globally.”

PRAIM does not close the conversation about AI in screening. But it shifts it from “does AI work?” to “how do we deploy it responsibly?” — a question that requires a different kind of evidence, and a different kind of infrastructure.