DermaSensor
DermaSensor
A handheld device using elastic scattering spectroscopy with an algorithmic classifier to assess whether a suspicious skin lesion warrants further evaluation, authorized for use by primary care clinicians.
At A Glance
- Manufacturer
- DermaSensor
- Medical specialty
- Dermatology
- Clearance route
- De Novo
- Year authorized
- 2024
- Modality
- Elastic scattering spectroscopy
- Role in workflow
- Clinical decision support
The authorized user is the point. This was not cleared for dermatologists, who already assess lesions well. It was authorized for primary care, where most suspicious lesions are actually first seen and where the miss rate is meaningfully higher.
Where It Is Used
- Primary care assessment of suspicious skin lesions
- Referral decision support where dermatology access is limited
- Reducing missed skin cancers outside dermatology
Limitations Worth Knowing
The device supports a referral decision and does not diagnose. It is indicated for lesions a clinician has already judged suspicious, so it does not address the lesion nobody examined. A reassuring result in a clinically concerning lesion does not override clinical judgment, and the device does not assess every skin cancer type equally.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.