NEVISENSE
SCIBASE ABNevisense is a device designed to assist dermatologists in detecting melanoma by measuring the electrical impedance of skin lesions. It helps provide additional information to decide whether a biopsy is necessary, aiming to improve early melanoma detection and reduce unnecessary biopsies.
Intended Use
Nevisense is indicated for use on cutaneous lesions suspected of melanoma to obtain additional information prior to biopsy, specifically for primary skin lesions between 2 mm and 20 mm in diameter, excluding clinically obvious melanoma and special anatomical sites.
Technology
Nevisense measures electrical impedance spectra via a probe with micro invasive electrode pins that penetrate the stratum corneum. It generates an electrical impedance spectroscopy (EIS) score that reflects tissue abnormality, processed and displayed on a touchscreen control unit.
Performance
Clinical multicenter, prospective pivotal study with 1951 patients and 2416 lesions, blinded design showed Nevisense sensitivity for melanoma detection of 95.9%, specificity of 31.3%. A multiple-reader study showed dermatologists' sensitivity improved by 6.4% with Nevisense aid. Safety profile showed no serious adverse events.
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