FDA Gives Nod to Marketing DermaSensor for Skin Lesion Evaluation

January 16, 2024

The device is designed to assist HCPs on referrals to dermatologists.

The U.S Food and Drug Administration (FDA) announced that it has granted authorization for marketing for the DermaSensor (DermaSensor Inc.) prescription device, indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and over.

According to a press statement, the device assists health care providers (HCPs) in determining whether to refer a patient to a dermatologist. Importantly, the announcement notes that the device should be used "in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists." It also cautions that the device should be used on lesions already assessed as suspicious for skin cancer, and it should not be used as a screening tool. The agency also said that the device should not be used as the sole diagnostic criterion and also that it should not be used to confirm a diagnosis of skin cancer.

The FDA is requiring that the manufacturer conduct additional post-market clinical validation performance testing in patients from demographic groups representative of the U.S. population. This includes populations with limited representation of melanomas in the premarket studies (due to low incidence of the disease).

Source: FDA Roundup: January 16, 2024

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