Cleo Skin has become the first AI tool in dermatopathology to hold both CE-IVDR certification and FDA Breakthrough Device Designation, according to a Primaa announcement.

The company received Breakthrough Device Designation from the FDA for Cleo Skin, its AI solution that helps pathologists diagnose skin cancers on digitized biopsy slides and excised tissues (FDA reference Q262799) on October 21, 2026. The designation gives Primaa prioritized interaction with the FDA ahead of its future U.S. submission. It does not constitute a marketing authorization.

Cleo Skin analyzes whole slide images of skin biopsies and excisions. It highlights areas suspicious for melanoma, provides an indicative lesion classification, including basal cell carcinoma, squamous cell carcinoma and nevus, and suggests key measurements such as margins, Breslow thickness and mitotic areas. Designed to assist, not replace, the pathologist’s review, it integrates into the image management systems laboratories already use.

In the United States, an exploratory study conducted with PathPresenter, in which seven pathologists reviewed 75 whole slide images with Cleo Skin integrated into their viewer, showed a 20% reduction in analysis time and a 17% improvement in sensitivity among junior pathologists.

The Breakthrough Device Designation recognizes the potential of innovative medical devices to address unmet medical needs and enables prioritized interactions with the FDA. With this designation, Primaa looks forward to engaging with the FDA through the Breakthrough Devices Program to advance Cleo Skin's U.S. regulatory pathway and prepare for its future market submission.

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