Voice AI Screening
[INQ. NO. 2610C10] AlzWIN analyzes a one-minute verbal test with AI to identify people at high risk of dementia. It supports cognitive screening, with final diagnosis carried out by medical professionals through further, multifaceted examinations of those referred for assessment.
The test begins with 30 seconds of practice, followed by one minute of naming words within a given category. Users can participate through a smartphone, tablet or ordinary telephone without installing an app, and results appear immediately.
A simple operating method supports use by older adults. The language-fluency format underpins a solution available in Korean, including dialects, Japanese and English, with each language version tested as part of the product’s development.
Research on the screening solution recorded sensitivity of 92% and specificity of 98%. In 2024 testing of Korean dialects, the AUC discrimination measure reached 0.979, adding a specific performance result to the solution’s language-based cognitive screening capabilities.
The solution was registered with the U.S. FDA in October 2024 as a Class II device assisting cognitive-function assessment. Approximately 77 U.S. clinics have adopted it or are in the process of adopting the solution in this supporting cognitive-assessment role.
A confirmatory clinical study for Korean MFDS authorization concluded successfully in August 2026, with authorization targeted for early 2027. The business has also obtained Korean medical-device manufacturing and quality-management recognition, ISO 13485:2016 and ISO/IEC 23894:2023 certifications.
Two versions serve medical professionals using the medical-device version and users of wellness applications. In Korea, the wellness version displays cognitive age relative to people in the same age group, supporting regular cognitive-health management at screening centers and welfare facilities.
More than 130,000 screenings have identified approximately 10,000 high-risk individuals, and the solution has been used in over 50 clinics and senior-related facilities. Its development has drawn on nine clinical studies and category verbal-fluency research published in international academic journals since 2013.
Japanese commercialization is being prepared with a local partner, following official adoption into a Japanese medical AI platform in November 2025. Collaboration opportunities also extend to overseas medical institutions, health-screening centers, insurance companies and international distributors.
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