The FDA has handed Breakthrough Device Designation to Cleo Skin, a tool from French developer Primaa that reads digitized skin biopsies and excisions and marks tissue suspicious for melanoma. The status buys the company earlier and more frequent dialogue with regulators ahead of a US premarket filing. It is not a clearance to sell.
Cleo Skin now holds European CE-IVDR certification, won in March 2026, alongside the FDA breakthrough tag, a first for any dermatopathology product. Beyond melanoma it returns indicative calls for basal cell carcinoma, squamous cell carcinoma and nevus, and it surfaces the measurements pathologists count by hand, among them margins, Breslow thickness and mitotic regions.
Junior readers gain the most
The SkinPerf2026 work put 313 whole slide images in front of 16 pathologists drawn from 11 French institutions. Melanoma sensitivity went from 83.8% to 88.6% across the group, and junior readers moved from 79.7% to 88.2%, closing the gap with seniors. Median time to flag mitoses fell 24%.
A smaller US evaluation, run with seven pathologists inside PathPresenter’s viewer, cut analysis time 20% and added 17% sensitivity for the junior cohort. Hugo Watel, Primaa’s chief operating officer, framed the designation as recognition for a tool built with pathologists rather than around them.
The clinical case rests on workload. Skin cancer leads US cancer incidence, with 234,680 fresh melanoma cases projected for 2026, and labs remain chronically short-staffed. Primaa is selling triage that keeps the clinician in charge, not an autonomous reader.
The next hurdle is a full US submission, where Cleo Skin will have to show accuracy holds across labs that digitize slides differently.
