Primaa's Cleo Skin AI Receives FDA Breakthrough Device Designation

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to Cleo Skin, an artificial intelligence solution designed to assist pathologists in diagnosing skin cancer. Developed by the company Primaa, the tool analyzes digitized biopsy slides and excised tissues to support clinical decision-making. This regulatory milestone marks a significant step for the technology as it prepares for a future submission in the United States. The designation provides the company with prioritized interaction with federal regulators to help address unmet medical needs. Cleo Skin is already certified under the European Union's In Vitro Diagnostic Regulation, making it the first AI tool in the field of dermatopathology to hold both credentials. The system is intended to act as a supportive colleague rather than a replacement for medical professionals. It highlights areas of interest on biopsy slides and proposes key measurements for the pathologist to review. By streamlining these routine tasks, the software allows doctors to focus their expert judgment on complex findings. Clinical validation for the tool included the SkinPerf2026 multicenter study, which evaluated its performance across 11 French institutions. In that trial, 16 pathologists reviewed 313 whole slide images to test the system's accuracy. The results showed that Cleo Skin improved overall melanoma sensitivity from 83.8% to 88.6%. Junior pathologists saw a particularly notable increase in sensitivity, which helped align their diagnostic performance with that of their more senior colleagues. An exploratory study conducted in the United States further demonstrated the tool's potential impact on clinical workflows. Seven pathologists reviewed 75 whole slide images using the software integrated directly into their existing viewer. The evaluation revealed a 20% reduction in analysis time alongside a 17% gain in diagnostic sensitivity for junior staff. Wonwoo Shon, the director of dermatopathology services at Cedars-Sinai Medical Center and founder of Aimes Diagnostics, noted that this type of human-AI collaboration represents the future of the field. He stated that the tool provides evidence-based support so that the necessary information is ready when the pathologist makes a final diagnosis. The integration of such systems into existing laboratory image management software is a key focus for developers. As AI continues to move into clinical practice, the industry is increasingly looking for ways to balance innovation with safety and accuracy. The FDA's breakthrough status recognizes the potential for this technology to improve patient outcomes in the diagnosis of skin cancer, which remains the most common form of cancer in the United States.