Nevisense
SciBase
Uses electrical impedance spectroscopy to assess lesions clinically suspicious for melanoma, producing a score intended to support the decision to biopsy.
At A Glance
- Manufacturer
- SciBase
- Medical specialty
- Dermatology
- Clearance route
- Premarket approval
- Year authorized
- 2017
- Modality
- Electrical impedance spectroscopy
- Role in workflow
- Clinical decision support
Nevisense is one of the few devices in this space to have gone through premarket approval rather than a clearance route, which reflects the risk classification of a device influencing a melanoma biopsy decision. PMA is a substantially heavier evidentiary burden and remains rare in medical AI.
Where It Is Used
- Melanoma biopsy decision support
- Assessment of clinically atypical pigmented lesions
Limitations Worth Knowing
Indicated for lesions already assessed as clinically atypical, and not a screening tool. High sensitivity comes with limited specificity, so it is far better at supporting a decision to biopsy than a decision not to. Lesion size and location constraints apply.
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.