DermaSensor raised primary care sensitivity for skin cancer

In FDA's review of DermaSensor, primary care physicians aided by the device referred skin cancers with 91.4% sensitivity, against 82.0% unaided; standalone sensitivity was 95.5%.

2
Benefit status
Reported
Evidence
Found by a court or regulator
Source published
Sources
1 publication
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Benefits

Benefit

Their sensitivity rose from 82.0% to 91.4%

Awaiting review

Outcome identifiers

Unresolved

Not reviewedUnresolved

Category

Improved Task Accuracy

Awaiting review

Status

Reported benefit

Awaiting review

Beneficiary groups

Organizations.

Awaiting review

Beneficiaries

Unresolved

Not reviewedUnresolved

Reach

Unresolved

Not reviewedUnresolved

Distribution and access

Unresolved

Not reviewedUnresolved

Duration

Unresolved

Not reviewedUnresolved

Expected?

Yes

Awaiting review

Costs and harms

Unresolved

Not reviewedUnresolved

AI system

System

DermaSensor

Awaiting review

Model

This is an explicit unresolved assignment: the sources on record do not settle this question.

Not reviewedUnresolved

Release

Unresolved

Not reviewedUnresolved

Provider

Unresolved

Not reviewedUnresolved

Role

Unresolved

Not reviewedUnresolved

Configuration

Unresolved

Not reviewedUnresolved

Inputs and outputs

Unresolved

Not reviewedUnresolved

Autonomy

Unresolved

Not reviewedUnresolved

Workflow

Physicians applied the device to lesions they already found suspicious. Physicians used the output as a second read after their own assessment.

Awaiting review

Human oversight

Unresolved

Not reviewedUnresolved

Relation to AI

In the reader study each physician judged every lesion with and without the device output, so the change in sensitivity is attributed to the device.

Awaiting review

AI contribution

In the reader study each physician judged every lesion with and without the device output, so the change in sensitivity is attributed to the device.

Awaiting review

Measurement

Studies

Study 1: quasi-experimental. Study 2: other. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Study design

Study 1: quasi-experimental. Study 2: other. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Measurement

Study 1: Multi-reader study; each lesion image viewed with and without device output in random order; refer or do not refer decision. Study 2: Prospective blinded standalone accuracy study against biopsy, with physician assessment on the same lesions. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Setting and sample

Study 1: 108 internal medicine or family practice physicians; 25 malignant and 25 benign lesions. Study 2: 1,005 patients, 1,579 lesions, 22 sites in the US and Australia. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Measures

Study 1: Referral sensitivity and specificity. Study 2: Sensitivity and specificity. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Comparison

Study 1: Unaided reads by the same physicians. Study 2: Primary care physicians on the same lesions. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Results

Study 1: Sensitivity 82.0% to 91.4%; specificity 44.2% to 32.4%. Study 2: Sensitivity 95.5% against 83.0%; specificity 20.7% against 54.2%. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Additional value from AI

Study 1: AUROC 0.708 to 0.762. Study 2: Not a with-and-without comparison. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Limitations

Study 1: Image-based reads; lower specificity; limited data for Fitzpatrick IV to VI. Study 2: Low specificity; under-40 sensitivity below 90%. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Denominators

Study 1: Two reads per lesion. Study 2: One device reading per lesion. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Materials for replication

Study 1: None public. Study 2: None public. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Money

Kind of value

The kind of monetary value is unclear.

Not reviewedUnresolved

Amount

The monetary value is not established.

Not reviewedUnresolved

Currency and prices

The currency and price basis are unclear.

Not reviewedUnresolved

Period and unit

The period and unit of the monetary estimate are unclear.

Not reviewedUnresolved

Realization

Whether the monetary value was realized is unclear.

Not reviewedUnresolved

Recipients and payers

The recipients and payers are unclear.

Not reviewedUnresolved

Gross or net

Whether the monetary figure includes costs is unclear.

Not reviewedUnresolved

Included costs

The costs included in the estimate are unclear.

Not reviewedUnresolved

Comparison

The financial comparison is not established.

Not reviewedUnresolved

Method

The method used to calculate monetary value is unclear.

Not reviewedUnresolved

Return and payback

The return on investment or payback period is not established.

Not reviewedUnresolved

People and places

Participants

Developer: DermaSensor, Inc. Operator: Primary care sites in the DERM-SUCCESS study.

Awaiting review

Jurisdictions

Benefit: Twenty-two sites in the United States and Australia. Developer: United States. Operator: United States; Australia.

Awaiting review

Ownership and control

Unresolved

Not reviewedUnresolved

Dependencies

Unresolved

Not reviewedUnresolved

Cross-border connections

Unresolved

Not reviewedUnresolved

Geopolitical implications

The geopolitical implications are unclear.

Not reviewedUnresolved

Follow-up

Conditions for replication

The patient is aged 40 or older. A dermatologist makes the final management decision after referral.

Awaiting review

Replication attempts

Unresolved

Not reviewedUnresolved

Later findings

Unresolved

Not reviewedUnresolved

Availability

Unresolved

Not reviewedUnresolved

Institutional decision

A relevant institutional decision has not been established.

Not reviewedUnresolved

Grounds

The grounds for an institutional decision are unclear.

Not reviewedUnresolved

Action and result

The result of an institutional decision is not established.

Not reviewedUnresolved

Success criterion

The criterion for a successful institutional decision is unclear.

Not reviewedUnresolved

Evidence

Source numbers

AIBD-0630-source-0001

Awaiting review

Citations

Numbered references below.

Awaiting review

Language

Unresolved

Not reviewedUnresolved

Source relationships

Independent

Awaiting review

Original evidence

Unresolved

Not reviewedUnresolved

Access and versions

Unresolved

Not reviewedUnresolved

Supported findings

Unresolved

Not reviewedUnresolved

Evidence strength

Found by a regulator. Sources: one independent regulatory document. The cited evidence includes no independent study or report. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Missing evidence

Unresolved

Not reviewedUnresolved

Grades

Assessed benefits

Organizations.

Awaiting review

Depth

Organizations: 2.

Awaiting review

Reasons

Organizations: Primary care physicians aided by the device reached 91.4% sensitivity for skin cancer referral against 82.0% unaided.

Awaiting review

Observed or intended

Unresolved

Not reviewedUnresolved

Rubric

Unresolved

Not reviewedUnresolved

Assessor and date

Unresolved

Not reviewedUnresolved

Alternative assessments

Unresolved

Not reviewedUnresolved

Fill

Found by a regulator

Awaiting review

Entry details

Kind

The case describes an evaluation or a study. A regulatory review of a pivotal study and reader studies. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Field

Healthcare.

Awaiting review

Purpose

DermaSensor was built to help physicians who are not dermatologists decide whether to refer a suspicious skin lesion. Better referral sensitivity is that purpose.

Awaiting review

Dates

Source published: 12 January 2024. Updated: 29 October 2026.

Awaiting review

Stage

The system was used in a pilot. A prospective pivotal study at 22 primary care sites plus reader studies before authorization. [1]

Fully reviewed

Review date: 29 October 2026.

Sources: [1]

Version

SHA-256: 638aa09a08a7…

Awaiting review

SHA-256 of the public case, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.

References

Other identifiers

Unresolved

Not reviewedUnresolved

Category mappings

Unresolved

Not reviewedUnresolved

Citable summary

Unresolved

Not reviewedUnresolved

Revisions

1 revision. Latest: 29 October 2026.

Awaiting review

Sources

  1. Regulatory document Independent author

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. De Novo classification request for DermaSensor (DEN230008): decision summary. Granted 2024-01-12.

Collections: Scrutiny and findings, Cross-border cases.

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Version 638aa09a08a7, archived in the edition of 29 October 2026

Benefit marks

Depth

The number and color show the depth of a benefit.

  1. A convenience, or time or money saved.
  2. A measurable improvement in a result or ability.
  3. A lasting change, an ability restored, or a risk removed.
  4. A serious harm averted or a serious condition resolved in time.
  5. A life or livelihood preserved, or a change documented across a population.

Beneficiary

  • Circle: a person
  • Square: an organization
  • Triangle: society

Evidence

  • Solid. A court or regulator found a benefit, or researchers independently studied it.

  • Hatched. Independent reporting.

  • Outline. Claimed by the parties. Only the people or organizations involved, or sources whose independence has not been assessed, support the benefit.

The fill changes with the evidence. The depth color stays the same.

How benefits are assessed