SciBase Files FDA 510(k) to Expand Nevisense Use for Non-Melanoma Skin Cancer

July 01, 2026
SciBase has submitted a 510(k) premarket notification to the U.S. FDA to expand the use of its AI device Nevisense to include non-melanoma skin cancers, aiming to broaden its clinical application beyond melanoma.

SciBase has announced in a press release the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration seeking to expand the indication of its AI-powered dermatology device Nevisense. The company aims to include the assessment of non-melanoma skin cancers, also known as keratinocyte skin cancers, within the device’s approved uses.

Nevisense is currently the only FDA-approved AI technology for the assessment and early detection of melanoma. If cleared, the expanded indication would allow clinicians to use the same platform for evaluating lesions with characteristics of basal cell carcinoma and squamous cell carcinoma, which together represent the most common form of cancer in the United States.

In Europe, Nevisense already carries CE marking for both melanoma and keratinocyte skin cancer. SciBase stated that this submission marks a key step in its strategy to extend the clinical application of its diagnostic technology in the U.S. market.

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