LifeSemantics wins nod for Korea’s 1st skin cancer diagnostic AI

LifeSemantics said Tuesday it obtained approval for Canofy MD SCAI, a medical AI solution that detects skin cancer, from the Ministry of Food and Drug Safety.

Canofy MD SCAI, the first software medical device licensed in Korea that uses images to assist in skin cancer diagnosis, has demonstrated clinical superiority in all indicators, including sensitivity, specificity, and accuracy, through confirmatory clinical trials.

According to LifeSemantics, Canofy MD SCAI utilizes image processing technology based on convolutional neural networks (CNNs) to fine-tune the classification of malignant and benign tumors. It identifies malignant melanoma, basal cell carcinoma, and squamous cell carcinoma, and benign tumors such as nevi, seborrheic keratoses, actinic keratoses, age spots, and lichen planus.

With the marketing approval, LifeSemantics plans to verify the safety, efficacy, and usability of Canofy MD SCAI in six medical institutions, including primary clinics and tertiary hospitals.