Medical imaging and radiology
Skin Analytics DERM
Class III CE-marked dermatology AI medical device used in UK skin cancer pathways to assess dermoscopic lesion images and support triage.
Last updated: June 14, 2026
Back to directoryDermaSensor medical AI product profile
FDA De Novo-cleared handheld device that uses AI-enabled elastic scattering spectroscopy to help trained physicians evaluate suspicious skin lesions.
Medical imaging and radiology
Best fit
Clinician-supervised primary-care or referral workflows that need objective support for suspicious melanoma, basal cell carcinoma, or squamous cell carcinoma lesions.
- Primary use case
- AI-assisted optical spectroscopy for adjunctive skin cancer risk assessment and dermatologist referral decisions
- Audience
- Primary care physicians, dermatology referral networks, health systems, and clinical governance teams evaluating suspicious-lesion assessment workflows
- Risk level
- High
- Pricing signal
- Subscription and device terms should be verified with DermaSensor for the current region, volume, and reimbursement workflow.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA De Novo authorized prescription adjunctive device for suspicious skin lesion evaluation. |
|---|---|
| Review route | De Novo DEN230008. |
| Intended use | Evaluates lesions suggestive of melanoma, basal cell carcinoma, or squamous cell carcinoma as an adjunctive second-read tool after clinician assessment. |
| Verification note | Confirm age limits, lesion exclusions, prescription-use requirements, training, Monitor versus Investigate Further workflow, and dermatology follow-up tracking. |
| Source | www.accessdata.fda.gov / cdrh_docs / reviews |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating DermaSensor as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as regulated prescription medical-device software and hardware; match use to DEN230008, age limits, lesion exclusions, trained users, adjunctive role, and post-market performance expectations. |
|---|---|
| Privacy | Review device connectivity, cloud synchronization, software updates, remote monitoring, identifiers, access controls, BAA terms, retention, and support workflows before clinical rollout. |
| Evidence | Assess FDA summary evidence and local pilot data for sensitivity, specificity, false reassurance, false referral, skin type, lesion location, and prevalence differences. |
| Workflow | Best governed as a suspicious-lesion referral aid where clinicians first identify eligible lesions, interpret the AI output with clinical findings, document decisions, and track biopsy or dermatology follow-up. |
Where DermaSensor fits
DermaSensor describes an FDA-cleared AI-powered skin cancer risk detection device for physicians that uses elastic scattering spectroscopy and returns Monitor or Investigate Further outputs; FDA's De Novo summary for DEN230008 states the device is an adjunctive second-read tool for suspicious lesions and is not standalone diagnosis, screening, biopsy replacement, or clinical-decision replacement.
Not for: At-home screening, standalone diagnosis, broad skin checks, lesions outside the cleared indication, or replacing dermatology referral and biopsy judgment.
What to verify before using DermaSensor
- FDA De Novo DEN230008, prescription-use limits, patient age, lesion exclusions, and whether the intended users match the cleared non-dermatologist physician workflow.
- Device training, spectral scan capture, output interpretation, referral thresholds, contraindications, warnings, and how results are documented in the record.
- Cloud synchronization, device monitoring, patient identifiers, support access, retention, BAA or privacy terms, and security review for connected-device use.
- Local performance for Fitzpatrick skin types, melanoma prevalence, prior biopsies, false negatives, false positives, referral burden, and dermatologist follow-up completion.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.dermasensor.com / skin-cancer-detection-device
- www.accessdata.fda.gov / cdrh_docs / reviews
- www.dermasensor.com / faq
- www.dermasensor.com / privacy-policy
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