Nevisense received Pre-Market Approval from FDA on June 28 2017 (PMA Number 150046), with the following Indication for use
Indication for use
Nevisense is indicated 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. Nevisense should not be used on clinically obvious melanoma.
The Nevisense result is one element of the overall clinical assessment. The output of Nevisense should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy.
Nevisense is indicated only for use on:
- primary skin lesions with a diameter between 2 mm and 20 mm;
- lesions that are accessible by the Nevisense probe;
- lesions where the skin is intact (i.e. non-ulcerated or non-bleeding lesions);
- lesions that do not contain a scar or fibrosis consistent with previous trauma;
- lesions not located in areas of psoriasis, eczema, acute sunburn or similar skin conditions;
- lesions not in hair-covered areas;
- lesions which do not contain foreign matter;
- lesions not on special anatomic sites (i.e. not for use on acral skin, genitalia, eyes, mucosal areas).
For a summary of Nevisense Labeling information please, click here