Dermalyser Secures CE Mark in Europe for AI-Powered Melanoma Detection Tool

Source: Dermatology Times, May 2025

Key Takeaways

  • Dermalyser, an AI-driven tool for melanoma diagnosis, has received CE mark certification, enabling its commercial use in Europe.
  • The tool integrates with smartphones and dermatoscopes, providing risk scores for melanoma based on dermoscopic image analysis.

AI Medical Technology (AIM) announced today that it has received CE mark certification for Dermalyser, its artificial intelligence (AI)-driven diagnostic decision support tool for melanoma.1 This regulatory milestone enables the tool’s immediate commercial use across Europe, with a US launch anticipated in 2027 pending FDA 510(k) clearance.

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