Swedish medical technology company SciBase Holding AB (STO: SCIB), a developer of AI-based diagnostic solutions for skin disorders, announced on Wednesday that it has submitted a 510(k) premarket notification to the US Food and Drug Administration seeking to broaden the US indication for its Nevisense platform to include assessment of keratinocyte skin cancers.

Nevisense is a point-of-care platform combining AI and electrical impedance spectroscopy for dermatological assessment. Scibase said it is currently the only FDA-approved AI-driven dermatology technology for melanoma detection.

Clearance of the expanded indication would extend Nevisense's clinical use to non-melanoma skin cancers and significantly increase its potential US market. The platform already holds CE marking in Europe for both melanoma and keratinocyte skin cancer, making the US filing a key step in SciBase's strategy to expand clinical adoption.

More than 5.4 million cases of basal cell carcinoma and squamous cell carcinoma are diagnosed annually in the United States, making keratinocyte skin cancer the most common cancer type. Squamous cell carcinoma can progress to metastatic disease if diagnosis is delayed, underscoring the need for objective tools that support earlier assessment and biopsy decisions.