nomela®
Intended use
nomela®is a non-invasive medical device applying machine-learning AI to assist clinicians when screening pigmented skin lesions (moles). The nomela® software, installed on dedicated single-application iPads, uses photographic digital imaging with on-device analysis technology to estimate the chance of melanoma for a suspect lesion.
The nomela® test is contraindicated for lesions which are: smaller than 5mm diameter; obscured by hair, tattoos or scars; in the mouth, eyelid, nailbed, acral (palmoplantar), 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, lymphoma or metastatic carcinoma.
No clinical data are available for use on patients under 16 years of age.
No clinical data are available for use on patients with dark skin (Fitzpatrick Type IV - VI).
Positioning
The management of patients with skin lesions under suspicion of melanoma in Primary Care or Community Screening.