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FDA authorises DermaSensor, an AI skin cancer checker for primary care doctors

See how this story connects

Source: FDA De Novo database: DEN230008 DermaSensorAlso reported by DermaSensor press release (Business Wire)

The FDA granted DermaSensor Inc.‘s De Novo request (DEN230008) on 12 January 2024, and the company announced it on 17 January. The handheld device uses spectroscopy and an AI algorithm to give primary care physicians an immediate result on lesions suspicious for melanoma, basal cell carcinoma and squamous cell carcinoma. The company reported 96% sensitivity across 224 skin cancers in a Mayo Clinic-led study of more than 1,000 patients at 22 centres.

Why it matters

US primary care physicians gained an FDA-authorised AI tool for skin cancer checks, and the De Novo grant created a new device class (21 CFR 878.1830) later products can cite.

When
17 Jan 2024
ID
WTA-N-2024-0003
Who
FDA, DermaSensor

Summary by wheresthe.ai, from FDA De Novo database and the reporting credited above. Checked against the source on 9 Oct 2026.

Read the original at FDA De Novo database

Source copy: download the page as saved on 18 Oct 2026 (PDF). Documents the source offers: document 1 (PDF), document 2 (PDF). Also held by the Internet Archive.

Next stop on this Storyline: What happened nextFDA proposes a risk framework for generative AI medical devices

Cite this story

WTA-N-2024-0003: “FDA authorises DermaSensor, an AI skin cancer checker for primary care doctors.” wheresthe.ai, 17 Jan 2024. https://wheresthe.ai/d/us-fda-dermasensor-de-novo-2024-01/ (source: FDA De Novo database: DEN230008 DermaSensor).

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