nomela®
Intended use
nomela®, a non-invasive diagnostic aid to indicate the chance of melanoma in pigmented skin lesions (moles) being a software medical device installed on single-application iPads applying machine-learning AI to captured images, is intended for use, after training, by medical professionals as an adjunct screening technology in the clinical pathway of the management of suspect lesions.
The nomela® test is contraindicated for lesions which are: smaller than 5mm diameter; obscured by hair, tattoos or scars; in the mouth, eyelid, nailbed, genital and perianal areas; ulcerated; non-pigmented which may be the amelanotic form of melanoma; likely to be basal cell carcinoma, squamous cell carcinoma, Merkel cell tumour.
Use of nomela® is not expected to be restricted by age. No clinical data are available (2025) for use on patients under 16 years of age.
Positioning
At present (2025) the intended positioning of nomela®, for the management of patients under suspicion of skin melanoma.