Skin · Diagnosis and imaging
DERM: AI skin-lesion triage that can send some likely-harmless moles off the urgent cancer pathway
DERM is AI that assesses photos of skin lesions referred on the urgent skin cancer pathway. In May 2025 NICE conditionally recommended it for NHS use in England for three years while more evidence is gathered. Evidence is less certain for black and brown skin, so NICE says those patients get an extra review by a healthcare professional. It doesn't replace checking your own skin.
How far away is this?
It's CE marked (the company's announcement; we haven't seen the certificate itself) and NICE has conditionally recommended it in England, where NHS services use it. NICE's recommendation is conditional and comes with an evidence-gathering period.
Where is it approved?
| Region | Regulator | Status | Notes |
|---|---|---|---|
| United States | FDA | The company lists FDA Breakthrough Device Designation. That's a faster review route, not authorisation to market.[3] | |
| European Union | CE mark / EMA | CE marked | Class III under EU MDR, per manufacturer announcement (Feb 2025). Certificate not independently checked.[2] |
| United Kingdom | MHRA | In use (MHRA record not verified) | NICE conditional recommendation, May 2025. NICE lists UKCA Class IIa certification (March 2022) under UK medical device rules; UK autonomous use relies on that UK certification, not the EU certificate. We haven't checked the MHRA register.[1] |
| Australia | TGA | Unknown |
CE marked Class III in the EU (company claim) and UKCA Class IIa in the UK (per NICE), in NHS use under a conditional NICE recommendation. Not authorised in the US. Australia unknown. "Unknown" means we haven't verified it, not that it's unavailable. Approval in one country isn't approval in another.
What is it?
A clinician takes a photo of a mole or lesion with a special lens attached to a smartphone. DERM analyses it and sorts it into likely cancer, needs a specialist, or likely benign. NICE says people whose lesions DERM classes as benign are taken off the urgent pathway and get their results with written advice from a healthcare professional. You are taken off the urgent skin cancer list, not discharged from care. If the mole changes, go back to your GP.
What's the evidence?
Skin Analytics says DERM received a Class III CE mark under EU MDR 2017/745 (announced February 2025). The company says this EU mark covers use without clinician review of lesions it classes as benign in the EU. In the UK, NICE lists DERM as UKCA certified as a Class IIa device (March 2022); a UK NHS-funded evaluation report says that UK certification is what allows it to be used without a clinician's final referral decision in the UK. We haven't seen either certificate ourselves.[4]
Evidence stage: Approved & in use · #c1
NICE conditionally recommended DERM for NHS use for three years while more evidence is collected (1 May 2025), as an early value assessment. It's for adults aged 18 or over, and can be used with or without healthcare professional review of lesions it identifies as non-cancer. For people with black or brown skin, NICE says an extra healthcare professional review should take place, because evidence is less certain.[1]
Evidence stage: Approved & in use · #c2
NICE says early evidence suggests automated use could roughly halve referrals to dermatologists in the urgent skin cancer pathway. That's an estimate of service efficiency, not proof that no cancers are missed. The key safety risk is a missed cancer, especially a melanoma wrongly classed as benign.[1]
Evidence stage: Approved & in use · #c3
What does it mean for me?
If you're referred with a worrying mole in some NHS areas, your photo may be checked by DERM first. Elsewhere it's unlikely you'll meet it yet. Keep checking your skin and see a doctor about any change; this tool doesn't replace that. Any mole that changes, bleeds or itches should be checked, even if it was previously called benign.
What could I ask my doctor?
- Will an AI tool look at my skin photo, and will a person also check it?
- What happens if the AI says my lesion is benign but I'm still worried?
- Has this tool been tested on skin like mine?
These are general starting points, not a recommendation to choose any particular test or treatment.
If you're worried about your health right now, contact your doctor or local health advice line. In an emergency, contact your local emergency number.
Change history
- : First published.
- : Updated after independent fact-check and clinical review
- : Review label corrected: this page was not clinically reviewed. Earlier labels saying 'independent fact-check' and 'clinical review' were wrong; checks so far were AI-assisted source checks only.
General information only, not medical advice. Talk to your doctor about your situation. AI-assisted source check. Not clinically reviewed.
References
- NICE news: conditional NHS recommendation (May 2025). nice.org.uk (2025). Official. https://www.nice.org.uk/news/articles/ai-skin-cancer-detection-system-gets-green-light-for-conditional-nhs-use
- Skin Analytics: Class III CE mark announcement (Feb 2025). skin-analytics.com (2025). Company document (claim). https://skin-analytics.com/news/regulatory-certification/derm-class-iii-ce-mark/
- Skin Analytics: certifications page. skin-analytics.com. Company document (claim). https://skin-analytics.com/ai-pathways/certifications/
- NICE MIB311: regulatory information (DERM UKCA Class IIa). nice.org.uk. Official. https://www.nice.org.uk/advice/mib311/chapter/Regulatory-information
- Evaluation of DERM skin cancer community diagnostic hub (NIHR-hosted report, 2025). hrc-sustainable.nihr.ac.uk (2025). Service evaluation report. https://hrc-sustainable.nihr.ac.uk/wp-content/uploads/2025/04/Evaluation-of-DERM-Skin-Cancer-Community-Diagnostic-Hub-March-2025.pdf
Publisher shown as the website hosting each source. Dates are given where the source label includes them.