AI Dermatology Platform Targets Early Detection of Non-Melanoma Skin Cancer

Delays in recognizing high‑risk lesions can result in metastatic disease in squamous cell carcinoma, underscoring the need for objective, point‑of‑care assessment tools. A new regulatory submission now seeks to broaden the U.S. use of an AI-enabled dermatology platform to assess suspicious lesions consistent with non‑melanoma skin cancer.

SciBase Holding AB has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to expand the U.S. indication for its Nevisense platform to include the assessment of non‑melanoma (keratinocyte) skin cancers. The filing seeks clearance for use on lesions with characteristics of keratinocyte skin cancer. Nevisense is currently the only FDA‑approved AI-driven technology in dermatology for the assessment and early detection of melanoma.

Nevisense is a point‑of‑care platform that combines AI with advanced measurement technology to enhance diagnostic accuracy and provide objective decision support for clinicians evaluating suspicious skin lesions. The proposed indication expansion would extend the platform’s clinical utility beyond melanoma to a broader range of skin cancers encountered in routine practice. In Europe, Nevisense holds CE marking for use in both melanoma and keratinocyte skin cancer.

The clinical burden targeted by the submission is substantial: 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 form of cancer. The company positions earlier, more objective assessment as a means to support more informed biopsy decisions. The submission is framed as a step in a broader strategy to expand the clinical application of the platform in the United States.

“This submission represents an important milestone for SciBase and our strategy to expand the clinical applications of Nevisense in the United States. Keratinocyte skin cancer is estimated to be the most common form of cancer, and we believe Nevisense has the potential to provide dermatologists with objective decision support across an even broader range of suspicious skin lesions. Expanding Nevisense beyond melanoma represents an important step toward supporting clinicians across the broader spectrum of skin cancers encountered in daily dermatology practice. We look forward to working closely with the FDA throughout the review process,” said Pia Renaudin, Chief Executive Officer of SciBase.

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