CadAI-B is an AI-powered one-stop solution designed to assist healthcare professionals in both the detection and differential diagnosis of breast cancer through ultrasound imaging. It operates in an on-device manner, eliminating the need for expensive external servers, and seamlessly integrates with ultrasound equipment to enable efficient real-time diagnosis during scanning.

The solution detects suspicious breast lesions in real time, visualizes them with outlines or color overlays, and provides key diagnostic information such as malignancy probability, BI-RADS category, Lexicon terms, and lesion size. It supports clinical decision-making with a range of functions tailored to real-world ultrasound settings, including Real-Time Mode (real-time detection), Freeze Mode (differential diagnosis), Measure Mode (automatic measurement), PACS transmission, preliminary auto-assessment, and Smart Check features.

CadAI-B has demonstrated strong performance with a sensitivity of 0.96, specificity of 0.80, AUC of 0.952, and an average detection time of 0.02 seconds per frame. It was designated as an Innovative Medical Device by the Ministry of Food and Drug Safety (MFDS) in December 2022 and became the first Class III medical device of its kind to receive approval in Korea in July 2024.

In addition to domestic regulatory milestones, CadAI-B has also been recognized internationally:

• Selected as a Next-Generation World-Class Product by the Ministry of Trade, Industry and Energy (November 2024)

• Obtained Import License in Vietnam from the Ministry of Health (September 2024)

• Received the KHF Innovation Award from the Minister of Health and Welfare (October 2024)

• Awarded by the MFDS Commissioner at the Annual General Meeting of the Korea Medical Devices Cooperative Association (February 2025)

These achievements highlight CadAI-B’s technological excellence and global competitiveness in the field of medical artificial intelligence.