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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.
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.
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.
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Additional information before biopsy of lesions with characteristics of melanoma, for dermatologists (PMA P150046) |
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Query for this drug: (TITLE:"Nevisense" OR ABSTRACT:"Nevisense" OR TITLE:"electrical impedance spectroscopy for melanoma, SciBase" OR ABSTRACT:"electrical impedance spectroscopy for melanoma, SciBase") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Nevisense (electrical impedance spectroscopy for melanoma, SciBase), not a curated reading list.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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