{"entity":{"id":"nevisense","kind":"drug","name":"Nevisense (electrical impedance spectroscopy for melanoma, SciBase)","aka":[],"tldr":"A probe that measures the electrical properties of a worrying mole to give a dermatologist more information before deciding on a biopsy, approved by the FDA in 2017.","summary":"Nevisense (SciBase AB, PMA P150046) was approved by the FDA on 28 June 2017 \"for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy\". It should not be used on clinically obvious melanoma, and the label limits it to intact primary lesions 2 to 20 millimetres across, away from scars, hair-covered areas and special sites such as acral skin, genitalia, eyes and mucosa. The result is one element of the overall clinical assessment.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P150046","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150046"}],"tags":["test","screening-test"],"related":["fda-device-databases"],"cancers":["melanoma"],"sections":["early-detection","diagnostics"],"technologies":["skin-cancer-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Nevisense","modality":"Electrical impedance spectroscopy test of skin lesions","mechanism":"A probe measures the electrical impedance of the skin lesion, and the device reports a result the dermatologist uses as additional information before deciding on a biopsy.","approvals":[{"region":"US","year":2017,"indication":"Additional information before biopsy of lesions with characteristics of melanoma, for dermatologists (PMA P150046)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/nevisense/","neighbours":{"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"skin-cancer-screening","kind":"technology","name":"Skin cancer screening (visual skin examination)","route":"/technologies/skin-cancer-screening/"}],"term":[{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}