Can AI check a mole for skin cancer?

The answer

Stage 5: regulator-cleared.

The rule that placed itA regulator has cleared or approved it for the task, where approval applies (for example the FDA for medical AI). Tasks no regulator covers are marked “No approval process exists”.

The evidenceSkin Analytics says its DERM system holds a Class III CE mark under EU rules that lets it clear patients it judges cancer-free without a doctor checking. Skin Analytics (company-reported), Feb 6, 2025.

A stage says how far the evidence has got. It is not a rating of the AI and not advice.

1
ClaimedEvidence found
2
LaunchedNo evidence yet
3
Independently testedEvidence found
4
Tested with real peopleEvidence found
5
Regulator-clearedPlaced here
6
Widely used with a verified recordNo evidence yet

The evidence

Everything we found.

In ladder order, newest first within each kind. Makers' own claims are labeled as theirs.

Claimed

What the makers claim

Skin Analytics (company-reported)
“DERM Zero delivers an autonomous clinical decision directly from a standard smartphone.”
Skin Analytics press release, PR Newswire · Jun 15, 2026 · company-reported
DermaSensor (company-reported)
“The ESS device was found to have a skin cancer detection rate, or sensitivity, of 96%.”
DermaSensor (company-reported) · Jun 12, 2025 · company-reported

Tested

What independent tests found

German Cancer Research Center, JAMA Dermatology meta-analysis
A 2026 review of 11 prospective studies (over 2,500 patients) found AI alone spotted melanoma about as well as dermatologists (80.9% vs 78.6% sensitivity), but most studies had a high risk of bias.
“AI systems perform at comparable levels to dermatologists for melanoma diagnostics”
JAMA Dermatology · Mar 25, 2026

Real people

Tested with real people

Field study, 10,925 patients at two NHS hospitals, 2021–2022 · run with the maker
In a maker-funded study of DERM in live NHS skin cancer pathways, it caught 95–100% of melanomas and judged 15–31% of cases fit for discharge.
“DERM identified 15.0–31.0% of cases as eligible for discharge.”
Frontiers in Medicine · Oct 31, 2023

Regulator

Rules and approvals

UK · Recommendation, not an approval · National Institute for Health and Care Excellence (NICE), as reported by Skin Analytics
Skin Analytics says NICE, which advises the NHS on which technologies to use, recommended DERM for the NHS. NICE is a health technology assessor, not a device regulator.
“Comparative evidence suggests that DERM may be able to identify a cancer lesion with similar accuracy to teledermatology”
Skin Analytics (company-reported) · May 1, 2025
EU · Approval · EU Medical Device Regulation 2017/745, Class III CE mark (company-reported)
Skin Analytics says its DERM system holds a Class III CE mark under EU rules that lets it clear patients it judges cancer-free without a doctor checking.
“DERM can now independently clear patients it determines don't have cancer, without requiring a doctor to check its work.”
Skin Analytics (company-reported) · Feb 6, 2025
US · Approval · US Food and Drug Administration
In January 2024 the FDA granted De Novo authorization to DermaSensor, a handheld AI device that helps physicians check lesions suspicious for skin cancer. It is for use by physicians.
“software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer”
FDA De Novo DEN230008 · Jan 12, 2024