SciBase Submits FDA 510(k) to Expand Nevisense into the Largest Skin Cancer Market
STOCKHOLM, Sweden – July 1, 2026 – SciBase Holding AB ("SciBase") [STO: SCIB) a leader in AI-based devices for detection and prevention in dermatology, today announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the U.S. indication for Nevisense to include the assessment of Non-Melanoma Skin Cancers (keratinocyte skin cancers).Nevisense is currently the only FDA-approved AI-driven technology in dermatology for the assessment and early detection of melanoma. If cleared, the expanded indication would extend the clinical