FDA grants Breakthrough Device Designation to Cleo Skin AI pathology tool
The FDA granted Breakthrough Device Designation to Cleo Skin's AI-based pathology tool on 6 November. The designation allows expedited interaction with the agency.
Who is affected and how
- medtech company
- The designation means faster dialogue with the regulator, but market authorisation still requires clinical evidence.
- doctor
- It is an early sign of AI support becoming available in dermatological pathology.
Sources
- FDA Grants Breakthrough Device Designation to Cleo Skin AI Pathology Toolclinical lab products · Nov 6, 2026
- US FDA Grants Breakthrough Device Designation to Primaa’s AI Dermatopathology Device: Here’s What Cleo Skin May Bring to the Tablethe dermatology digest · Nov 6, 2026
- FDA Grants Breakthrough Device Status to Cleo Skin AI Pathology Toolclpmag.com · Nov 6, 2026
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