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Last updated: June 5, 2026
Back to directoryClass III CE-marked dermatology AI medical device used in UK skin cancer pathways to assess dermoscopic lesion images and support triage.
Governed dermatology services evaluating AI-enabled teledermatology triage with post-market surveillance and clinician-reviewed pathway design.
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Product-specific review. These product-specific signals summarize what the cited sources imply before treating Skin Analytics DERM as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Verify the exact jurisdiction and pathway because CE-marked UK deployment, MHRA oversight, NHS use, and U.S. investigational status create different obligations. |
|---|---|
| Privacy | Review dermatology-image capture, teledermatology routing, identifiers, data protection, ISO 27001, GDPR, NHS DSP Toolkit, DTAC, retention, support access, and patient notice. |
| Evidence | Use post-market surveillance and independent evaluations as starting evidence, then validate local imaging quality, lesion mix, melanoma prevalence, equity, and escalation outcomes. |
| Workflow | Best governed as a pathway-level triage system with explicit image acquisition standards, dermatologist review rules, safety-netting, audit, incident review, and patient communication. |
Skin Analytics states that DERM is a Class III CE-marked AI as a Medical Device for skin cancer, has been deployed across NHS pathways, and publishes post-market performance, certifications, clinical evidence, and information-security materials; its site also notes U.S. investigational-device limitations.
Not for: U.S. commercial clinical use without confirming investigational limits, unsupervised consumer diagnosis, or deployment outside supported imaging and referral pathways.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.