FDA-cleared AI diagnostic tools already displacing referral volume
#1The FDA has cleared multiple AI-based dermatology diagnostic tools under the De Novo and 510(k) pathways, including DermTech's melanoma genomic test (ADLT-designated 2021), Optain's AI for actinic keratosis screening, and several AI-backed teledermatology triage tools. These clearances allow non-dermatologist clinicians — PCPs, urgent care providers, and NPs — to use AI to make definitive or near-definitive assessments on lesions that would historically have generated a dermatology referral. The pipeline of pending FDA clearances for AI dermatology tools includes over 30 products as of early 2026.