DERM (by Skin Analytics)
Overview
DERM (Deep Ensemble for the Recognition of Malignancy) by Skin Analytics is an AI as a Medical Device (AIaMD) with Class III CE mark that assesses dermoscopic images of skin lesions to provide a suspected diagnosis and referral recommendation. It aims to triage patients and reduce waiting times for skin cancer assessment. The AI system analyzes dermoscopic images of skin lesions, classifying them as benign or cancerous. DERM is intended for use in the screening, triage, and assessment of skin lesions suspicious for skin cancer in patients aged 18 years or over. It does not provide a definitive diagnosis for skin cancer. DERM is deployed within an imaging clinic prior to a dermatologist appointment, especially for urgent suspected skin cancer referrals. The technology has shown high accuracy in ruling out melanoma (99.7%) and can significantly reduce urgent suspected cancer referrals to secondary care.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Autonomous triage of skin lesions using AI
- Assessment of dermoscopic images for suspected skin cancer
- Provides suspected diagnosis and referral recommendation
- High accuracy in ruling out melanoma (99.7%)
- Reduces urgent suspected cancer referrals
- Supports autonomous discharge of low-risk cases
- Compatible with approved dermoscopic hardware systems and certain smartphones
- Integration with third-party client software systems via API
- Post-market surveillance and performance monitoring
- Classifies 11 different lesion types
Use Cases
- Triage of urgent suspected skin cancer referrals
- Streamlining early diagnostic skin cancer assessments in community diagnostic hubs
- Reducing waiting times for skin cancer assessment
- Supporting clinical decision-making for primary and secondary care clinicians
- Automated clinical management tool in skin cancer pathways
- Remote skin assessment services
What Physicians Need to Know
DERM is a powerful AI tool for triaging suspected skin cancer, but it's crucial to remember it does not provide a definitive diagnosis. Always integrate DERM's output with all other clinical information for patient management. While DERM can autonomously discharge low-risk cases, consider local pathway guidelines and patient anxiety when communicating results. Ensure images submitted for analysis are captured using approved dermoscopic hardware for optimal accuracy. Stay informed about the latest performance reports and updates from Skin Analytics.
DERM requires integration with a client system via an API. Skin Analytics offers an onboarding process to facilitate this. The system is designed to integrate into existing teledermatology and urgent suspected skin cancer pathways, enabling automated clinical management activities like referral letter generation. It's important to note that DERM is a standalone software device and cannot be white-labeled.
Details
| Category | Clinical Decision Support & Reference, Dermatology AI, Oncology AI |
| Pricing | Unknown — unknown |
| Deployment | Cloud-based, integrated with third-party client software systems |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Unknown AI-estimated DERM has received FDA Breakthrough Device Designation. Skin Analytics is building DERM to meet the level of compliance required by Class III US FDA regulation. |
| Integrations | |
| EHR | Not specified |
| Specialties | Dermatology, Oncology, Pathology |
What the Web Says
DERM by Skin Analytics is an AI-powered medical device designed to assess dermoscopic images of skin lesions for skin cancer, aiming to improve efficiency and reduce waiting times in dermatology. It has received positive endorsements from NICE and NHS England, and is currently used in numerous NHS sites and by private healthcare providers. The technology is praised for its high accuracy in detecting malignant lesions and safely discharging benign ones, often performing as well as or better than dermatologists. While generally well-received, some physicians express caution regarding autonomous AI diagnoses without clinician oversight, and there are mentions of the AI being overly cautious in some cases.
Overall: PositiveStrengths
- High accuracy in detecting malignant lesions (97-99.8% sensitivity for melanoma).
- Effectively triages high-risk lesions and safely discharges benign ones, reducing unnecessary referrals.
- Frees up clinician capacity and reduces waiting times for dermatology appointments.
- Cost-effective, with potential for significant savings for healthcare systems.
- Patients report positive experiences, appreciating the speed, efficiency, and accessibility of the service.
- First AI tool legally authorized to independently make clinical decisions on skin cancer without oversight in Europe (Class III CE marking).
Limitations
- Some physicians express concerns about fully autonomous AI diagnoses without human clinician review.
- AI can be overly cautious, flagging benign moles as potentially malignant, leading to patient anxiety and unnecessary procedures.
- Initial skepticism from some patients regarding the non-clinical setting and use of a smartphone for imaging.
- Challenges in developing safety-critical technologies, with a long development timeline.
- The wording of AI-generated letters to patients can be confusing or lack clear diagnostic confirmation.
- Some Reddit discussions about other 'Derm Skincare' or 'AI Dermatologist' apps highlight issues with unexpected charges and poor customer support, though these do not appear to be directly related to DERM by Skin Analytics.
Based on reviews from: Digital Health, Nice recommends first AI medical device for skin cancer diagnosis in the NHS, Evening Standard, BioWorld, Skin Analytics (DERM) performance - Skin Analytics, Real-world post-deployment performance of a novel machine learning-based digital health technology for skin lesion assessment and suggestions for post-market surveillance - PMC, Reddit (r/Melanoma, r/GPUK, r/Dermatology), NHS England, University of Surrey, Skin Analytics (Claire's story) - Skin Analytics, Response to the British Association of Dermatologists Letter - December 2022, Accuracy of an artificial intelligence as a medical device as part of a UK-based skin cancer teledermatology service - PMC, Unity Insights, SBRI Healthcare, AI Shown to Outperform Human Experts for Skin Cancer Detection u2013 NHS England Report, PR Newswire, Apple App Store
Last updated: 2026-07-27
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