AIVIS, a leading medical AI company specializing in digital pathology, announced that it has received regulatory approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its latest AI-powered in vitro diagnostic software, Qanti Ki-67 Micro. The newly approved solution enables automated quantification of Ki-67—a key biomarker used to assess tumor cell proliferation—using only microscope-captured images, reducing reliance on capital-intensive digital scanners and offering a more accessible alternative.

Qanti Ki-67 Micro marks a significant step forward in the accessibility of AI-driven diagnostics in detecting and quantifying Ki-67. By eliminating the need for costly whole slide imaging infrastructure, the solution empowers more hospitals and laboratories—particularly in resource-limited settings—to adopt advanced diagnostic technologies.

This milestone builds on the success of AIVIS’s Qanti IHC lineup, which already includes MFDS-approved tools for the quantification of ER, PR, HER2, and Ki-67 using digitized slides. The development of Qanti Ki-67 Micro reflects AIVIS’s commitment to supporting institutions that have not yet implemented full-scale digital pathology systems.

AIVIS has reinforced its dedication to quality and safety through a robust quality management system aligned with GMP and ISO 13485 standards. The company regularly updates its AI models and software systems to ensure optimal performance. According to AIVIS’s Head of Regulatory and Quality Affairs, the smooth approval process reflects the company’s thorough oversight across the entire product lifecycle—from development to post-market surveillance. AIVIS plans to continue investing in quality systems to meet evolving global regulatory standards.

With MFDS approval, Korean healthcare providers are now eligible to seek reimbursement for using Qanti Ki-67 Micro, substantially lowering the financial barrier to adopting AI-enhanced diagnostic tools. AIVIS will also provide training and implementation support to ensure a seamless integration into clinical workflows.

The solution was officially introduced at USCAP 2025 in Boston, one of the world’s leading pathology conferences. It drew significant international attention and inquiries from institutions across North America, Europe, and Asia, aligning with AIVIS’s global expansion strategy.

“This regulatory milestone reaffirms our mission to make AI-powered diagnostics more accessible and practical. By offering solutions that are not only high-performing but also infrastructure-independent, we are helping more healthcare providers enhance diagnostic precision and improve patient outcomes,”

said Daehong Lee, CEO of AIVIS.

AIVIS continues to grow through strategic collaborations with more than 20 leading hospitals in South Korea and global partnerships with organizations such as Philips, advancing both diagnostic accuracy and AI-driven drug development.

About AIVIS

AIVIS is a South Korea-based medical AI company driving innovation in digital pathology. Its flagship solution, Qanti IHC, provides automated quantification of key biomarkers—including ER, PR, HER2, and Ki-67—with exceptional capability in detecting HER2-low and ultralow cases. Backed by MFDS approval and a growing global presence, AIVIS is dedicated to advancing diagnostic accuracy and enabling AI-powered precision medicine worldwide.