FDA Clears AI-Powered Handheld Device That Can Detect Skin Cancer

Topline

The FDA has cleared DermaSensor’s first-of-its-kind handheld device that uses artificial intelligence to non-invasively detect skin cancer, the Miami-based device maker announced Wednesday.

Key Facts

Physicians may use the device to take spectral recordings of a suspicious skin lesion, which then goes through an AI-powered algorithm to deliver an immediate result, according to DermaSensor’s website.

The device can detect all three common types of skin cancer—basal cell carcinoma, squamous cell carcinoma and melanoma, which is the most deadly form of skin cancer—and signals to physicians whether a suspicious lesion should be investigated further.

The FDA authorized marketing for the device last week, noting that the device should be used on lesions already assessed as suspicious for skin cancer and should not be the only diagnostic criterion.

The FDA is also requiring that DermaSensor conduct additional post-market clinical validation performance testing of the DermaSensor device across demographic groups.

According to Reuters, the device will be priced through a subscription model at $199 a month for five patients or $399 a month for unlimited use.

Key Background

Doctors are typically reliant on subjective physician judgment using the naked eye or through a microscope, but a study last year found that DermaScope had a sensitivity of 96% across all 224 forms of skin cancer and across different skin types. The device comes as advances in artificial intelligence continue to drive new innovation in the medical field. Google, for instance, is developing an AI-powered chatbot that will be able to conduct medical interviews and make diagnoses.

Surprising Fact

Another study on DermaSensor found that in a clinical cohort of 108 physicians, the DermaSensor device reduced the number of missed skin cancer diagnoses by half—from 18% to 9%.