Germany's national LDCT lung cancer screening program launches in April 2026 with mandatory AI-assisted detection. Below are the most frequently asked questions from hospitals and radiology groups evaluating their AI infrastructure for program participation.
Regulatory Compliance
Does AVIEW LCS Plus meet the LuKrFrühErkV requirement for "qualified computer-assisted detection software"?
Yes. AVIEW LCS Plus is designed for automated pulmonary nodule detection and analysis on low-dose CT — the exact use case mandated by the Lung Cancer Early Detection Ordinance (LuKrFrühErkV). The solution holds CE marking under the EU Medical Device Regulation (MDR), FDA clearance, and full HIPAA and GDPR compliance. It has also been validated in Germany's HANSE pilot program — the government-led screening study that informed the G-BA's decision to establish the national program.
Is CE marking sufficient, or are additional certifications required?
CE marking under MDR is the baseline regulatory requirement for medical device software in Germany. Beyond that, the G-BA Cancer Screening Directive sets quality requirements for the CT equipment, the reading workstation, and the CAD software used in the screening workflow. Coreline Soft works with participating institutions to ensure full alignment with these requirements as part of the implementation process.
Workflow Integration
How does AVIEW LCS Plus integrate with existing PACS and RIS?
AVIEW LCS Plus supports standard DICOM connectivity and integrates with existing PACS and RIS environments. The solution can operate as a standalone workstation or be embedded within third-party platforms — including Bayer's Calantic Medical Imaging platform, through which Coreline Soft has an active partnership. Integration scope, supported communication protocols, and timeline depend on the specific IT environment and are assessed during the onboarding process.
How does the software support the mandatory dual-reading workflow?
Germany's screening program requires an independent second reading and a consensus recommendation for suspicious or monitoring-required findings. AVIEW LCS Plus provides standardized nodule detection and measurement for both primary and second readers, ensuring that both opinions are based on the same AI-assisted analysis baseline. This is particularly important when primary and second readers are at different institutions — the software ensures consistency regardless of site.
How do primary and secondary reading sites exchange data in Germany's screening program?
The G-BA requires an independent second reading for suspicious findings, but does not prescribe the technical method for data exchange between institutions. Coreline Soft addresses this with two distinct products: AVIEW, installed at the primary reading site, performs AI-assisted detection and supports the first reading. When findings meet a defined threshold (e.g., Lung-RADS ≥ 3), the case is transmitted to AVIEW:HUB, installed at the certified lung cancer center where the second reading takes place. The second reader accesses the case — including the AI analysis baseline generated at the primary site — through AVIEW:HUB's web-based viewer. AVIEW:HUB routes cases to a consensus stage for final verification, including cases with discrepant results, with full audit documentation. This architecture ensures that first readers work exclusively on AVIEW and certified second readers work exclusively on AVIEW:HUB, simplifying user management and access control.
Multi-Site Operations
How do you ensure consistent detection quality across multiple screening sites?
This is the core operational challenge created by the reimbursement framework — and it is central to what AVIEW LCS Plus is built for. The solution applies the same detection algorithms and measurement protocols across all sites, eliminating variability that arises from differences in reader experience, workstation configurations, or local practices. For hospital groups and radiology networks operating across multiple locations, this provides the standardized quality baseline that the national program demands.
Is there centralized monitoring or quality dashboards for multi-site deployments?
Coreline Soft supports deployment configurations that enable oversight across multiple sites. Specific monitoring and reporting capabilities can be discussed based on the operational structure and scale of your screening program.
Structured Reporting & Longitudinal Tracking
Does the software generate structured reports aligned with German screening guidelines?
AVIEW LCS Plus produces standardized nodule analysis outputs — including size, location, volume, and characteristics — that support the structured reporting workflows required by the Cancer Screening Directive. These outputs can be incorporated into your institution's reporting templates to meet documentation requirements for both primary and second readings.
Can the software automatically compare nodules across 12-month follow-up scans?
Yes. Longitudinal nodule tracking is a core capability of AVIEW LCS Plus. When a patient returns for a follow-up LDCT (the scenario covered by billing code GOP 01872), the software automatically matches previously identified nodules and calculates volumetric changes over time. This enables objective growth assessment and supports the clinical decision on whether further workup is needed — a critical function in the mandatory dual-reading and consensus workflow.
Evidence & Track Record
What results came out of the HANSE pilot program?
The HANSE study (Hanseatic Screening Project) was conducted across three certified lung cancer centers in northern Germany — Hannover Medical School, University Hospital Schleswig-Holstein (Lübeck), and LungenClinic Grosshansdorf. AVIEW LCS Plus was the sole AI software deployed throughout the study. HANSE was one of the key studies that informed the G-BA's decision to establish the national screening program, contributing to the evidence base for AI-assisted LDCT screening in Germany. Specific clinical outcomes and published data are available upon request.
Which German hospitals currently use AVIEW LCS Plus?
Coreline Soft currently supplies AVIEW LCS Plus to over 60% of Germany's top 10 hospitals. These include Charité – Universitätsmedizin Berlin, Medizinische Hochschule Hannover (MHH), Technische Universität München (TUM), Cologne University Hospital, Klinikum Chemnitz (a public hospital in Saxony), and Quartz. The solution is also deployed in several major European national lung cancer screening programs, including RISP, IMPULSION, and 4-IN THE LUNG RUN.
Pricing & Deployment
What is the licensing model?
Coreline Soft offers flexible licensing models tailored to the scale and structure of the screening program — whether single-site, multi-site, or network-wide deployments.
How long does implementation typically take?
Implementation timelines vary based on IT infrastructure and integration requirements. For institutions with standard PACS/DICOM environments, deployment can typically be completed within a matter of weeks. Coreline Soft provides dedicated onboarding support including technical integration, workflow configuration, and user training.
Have a question not covered here? Contact us at
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