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Dermatology assessment

DermaSensor

DermaSensor

Uses optical spectroscopy and a locked algorithm to assess suspicious skin lesions and support referral decisions.

Designed for

Physician

Care setting

Primary care

Specialty

Dermatology, Primary care

Public evidence assessedReviewed August 31, 2026

Our assessment

Bottom line

DermaSensor has a strong prospective pivotal study with pathology confirmation and broad site participation, supporting an adjunctive referral role. Its high-sensitivity strategy leaves important real-world questions about specificity, referral volume, skin-tone performance, false reassurance, and long-term outcomes.

Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.

What the evidence supports

Reviewed sources establish an FDA-authorized adjunct that provides a risk signal for defined suspicious skin lesions in primary care.

What remains uncertain

Real-world specificity, performance across skin tones and lesion types, referral behavior, and long-term outcomes require continued study.

How it was studied

The FDA De Novo review describes DERM-SUCCESS, an international prospective blinded study at 22 sites. It enrolled 1,005 participants with 1,579 suspicious lesions, biopsied every enrolled lesion, and compared device output with centrally confirmed dermatopathology.

Product facts

Intended use
Assist physicians evaluating lesions suggestive of melanoma, basal cell carcinoma, or squamous cell carcinoma in deciding whether further care is needed.
Represented version
FDA-authorized DermaSensor device represented by DEN230008
Regulatory context
DermaSensor received FDA De Novo authorization under DEN230008. It assists referral decisions and is not a standalone cancer diagnosis.

Sources reviewed

2 public sources represented in this evidence profile.

FDA De Novo review and DERM-SUCCESS studyRegulatoryDermaSensor product overviewOfficial product
For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

FDA-reviewed developer-sponsored pivotal evidence with pathology reference standards. Independent pragmatic post-market evaluation remains important.

Important limitation

High-sensitivity pivotal testing does not establish real-world specificity, performance across all skin tones and lesion subtypes, referral burden, false reassurance, or long-term cancer outcomes.

Questions to ask

  1. 01How does performance vary across skin tones and lesion subtypes?
  2. 02How are negative results reconciled with clinical concern?
  3. 03What effect does use have on referral volume and missed cancers?
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