AIVIS presents a digital pathology solution at KIMES 2025 ‘INSPIRE’ special zone скачать в хорошем качестве

AIVIS presents a digital pathology solution at KIMES 2025 ‘INSPIRE’ special zone

AIVIS Inc. (CEO Daehong Lee) participated in the ‘KIMES INSPIRE’ special zone at KIMES 2025 (The 40th Korea International Medical & Hospital Equipment Show), held from March 20 to 23 at COEX in Seoul. Founded in 2021 by a team of Ph.D. and master’s degree researchers specializing in image processing and AI, together with medical professionals, AIVIS aims to provide digital pathology solutions that enable more precise cancer diagnosis and treatment. The company is actively pursuing R&D and market expansion to become a global leader in digital pathology. AIVIS has developed a proprietary algorithm that can quantify HER2 ultra-low expression, enabling objective analysis of subtle expression patterns that are difficult to distinguish through conventional pathology review. The product has received regulatory approval from Korea’s Ministry of Food and Drug Safety (MFDS). AIVIS has partnered with Philips and AstraZeneca to supply products to medical institutions in Korea and abroad. The company also offers AI-based precision diagnostics for breast, thyroid, and colorectal cancers. AIVIS explained that its foundation stemmed from the academic goal of applying image processing and AI to medical fields and the recognition of real-world clinical challenges. While AI has sparked innovation across industries, pathology often remains analog. AIVIS believes that revolutionizing pathology with AI can reduce the burden on clinicians and improve patient outcomes. The company emphasized the importance of immunohistochemistry (IHC) analysis in evaluating biomarkers for treatment decisions. Since pathologists often rely on subjective experience, consistent diagnostics can be difficult. The founders envisioned an AI-powered, objective, and standardized solution to quantify IHC biomarkers and automatically support more reliable clinical decision-making. They also noted that a shortage of pathologists and increased diagnostic demands are significant global healthcare issues that AI-based solutions can help resolve. Through its digital pathology solution, AIVIS aims to enable accurate cancer diagnosis, optimize treatment strategies, and support efficient workflows for healthcare professionals. At KIMES 2025 Inspire Zone, AIVIS showcased its MFDS-approved software medical device, ‘PathoAiD-Qanti IHC,’ a digital pathology solution. This product analyzes high-resolution images obtained through digital pathology scanners using AI, supplementing subjective pathologist assessments and automatically quantifying biomarkers like HER2, ER, PR, and Ki-67. The technology’s ability to measure HER2 low and ultra-low expression drew strong interest from pathology and pharmaceutical experts globally. An AIVIS representative stated, “KIMES Inspire Zone allowed us to widely introduce our AI pathology solutions to medical device distribution and investment stakeholders. Many showed interest in Qanti IHC, and the setup enabled direct discussions about the solution’s features and applications. We also engaged in deep conversations with companies interested in preclinical research and pathology AI implementation.” With successful proof-of-concept and commercialization in over 20 Korean medical institutions, AIVIS emphasized that its product has proven clinical utility. The company said the exhibition was a meaningful opportunity to highlight its technological innovation. AIVIS also addressed the challenges faced by the Korean market. “The biggest obstacles in developing and commercializing AI medical devices in Korea are data access and regulatory compliance. Acquiring large pathology image datasets requires close collaboration with hospitals, but privacy laws and institutional procedures can limit access. To address this, we conduct joint PoC projects with major hospitals and use anonymization techniques to mitigate ethical and legal concerns,” said the representative. “Another challenge is the need for agile regulatory compliance as software as a medical device (SaMD) becomes more integrated into digital healthcare. Although we proactively obtained MFDS approval, ISO13485, and GMP certification, regulatory standards for innovative technologies are still evolving. We hope for closer communication between regulators and companies to facilitate smoother commercialization.” [AVING USA] https://us.aving.net/news/articleView...