Coreline Soft has been recognized among leading global companies based on the number of U.S. FDA-cleared AI-powered medical devices. As of the second half of 2025, a cumulative total of 1,357 AI-based medical devices have received FDA clearance. By specialty, radiology accounts for approximately 77% of approvals, followed by cardiovascular medicine (10%), neurology (4%), and anesthesiology (2%).
Within this landscape, Coreline Soft has obtained FDA clearance for nine AI algorithms, placing the company among a limited group of global providers with multiple cleared products. In Korea, Coreline Soft is recognized as one of the leading companies in terms of FDA-cleared medical AI portfolios. Rather than relying on a single product, the company has accumulated repeated regulatory clearance experience and real-world clinical references across multiple solutions, forming a business structure designed to scale under increasingly stringent regulatory environments.
As global competition in medical AI evolves, industry focus is gradually shifting from standalone algorithm accuracy toward regulatory readiness, operational deployment, and long-term scalability. In this context, Coreline Soft’s positioning reflects broader market trends emphasizing practical implementation and workflow integration.
The company’s AVIEW platform enables the simultaneous analysis of lung cancer, chronic obstructive pulmonary disease (COPD), and coronary artery calcification from a single low-dose chest CT scan. Beyond algorithmic analysis, the platform integrates structured reporting, prioritization support, and quality monitoring tools, supporting workflow-oriented clinical use rather than isolated diagnostic output.
AVIEW has been applied in real-world clinical settings across 19 countries, with cumulative use exceeding 2.5 million cases, demonstrating stability and applicability in routine practice. The platform has also been utilized in regionally coordinated and publicly supported lung screening initiatives in Europe, indicating its suitability for population-level screening environments.
Clinical and research activity continues to expand alongside deployment. More than 400 peer-reviewed publications related to medical AI have been produced in collaboration with clinical and academic institutions.
Recent studies published in the European Journal of Cancer evaluated the role of AI-assisted analysis in supporting assessment not only at baseline but also during follow-up intervals, including three- and twelve-month scans. These findings address key considerations for longitudinal screening and monitoring programs.
From an intellectual property perspective, Coreline Soft has strengthened its U.S. patent portfolio, securing additional patents related to high-precision AI technologies and surpassing 20 registered U.S. patents in total. The company is also expanding its presence within the global healthcare ecosystem through collaborations with international technology, pharmaceutical, and academic organizations, supporting broader adoption in North American and European markets.
Industry observers note that, beginning in 2025, competition in medical AI is increasingly defined by the ability to operate AI solutions across multi-institutional workflows under evolving regulatory frameworks. As regulatory requirements become more structured and the importance of real-world clinical data continues to grow, companies with demonstrated clearance experience, operational references, and protected intellectual property are positioned to expand more effectively. Coreline Soft’s inclusion among leading global companies in FDA-cleared medical AI reflects this broader transition toward operational AI infrastructure and highlights the company’s execution capability in global markets.
2026.01.14
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