[Medical Imaging AI Infrastructure ⑧] Korean Imaging AI Must Turn Overseas Clearance into Sustained Clinical Use

The report emphasizes that regulatory clearance, such as US FDA authorization or European CE marking, is only an initial step for Korean medical imaging AI companies. Achieving global competitiveness depends on turning these clearances into routine hospital use, contract renewals, and sustained revenue. Products must fit local clinical workflows and payment systems, while also providing evidence of performance after deployment and patient benefit. Entering the US market, for example, requires navigating reimbursement, hospital budgets, and demonstrating how AI can accelerate treatment or reduce repeat imaging.

CorelineSoft’s activities in the US highlight the challenge of continued adoption. Its medical imaging postprocessing product, AVIEW, saw a fourth-year subscription renewal by 3DR Labs, with annual usage reportedly increasing by 60%. While this suggests customer retention and integration into workflows, the report notes that usage growth alone does not establish revenue or profitability, as contract terms and support costs are vital to the financial result.

In Europe, CorelineSoft secured 77 new hospital contracts in Germany for its lung-nodule computer-aided detection product. This aligns with Germany’s recent introduction of low-dose CT lung cancer screening, which creates demand for AI tools that assist with detection and tracking. These contracts expand the potential installation base, but the report clarifies they do not equate to operational sites or national market share; activation dates and examination volumes will show how the base develops. In Japan, CorelineSoft’s lung-nodule product received ministry approval following a PMDA review, navigating a country-specific certification process which does not itself establish superiority over competing products.