• Posted January 18, 2024

FDA Approves AI Device That Helps Spot Skin Cancer

THURSDAY, Jan. 18, 2024 (HealthDay news) -- The first medical device powered by artificial intelligence and designed to help doctors catch skin cancer has been approved by the U.S. Food and Drug Administration.

Although not meant to be used as a primary screening tool, the technology further evaluates skin lesions that doctors have already flagged as suspicious, the FDA noted in an agency news release.

The handheld device uses AI-powered spectroscopy to assess the characteristics of lesions at both the cellular level and beneath the skin's surface.

“We are entering the golden age of predictive and generative artificial intelligence in healthcare, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care,” DermaSensor Inc. co-founder and CEO Cody Simmons said in a company news release. “Equipping PCPs [primary care physicians], the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine.”

The device, also called DermaSensor, provides real-time results using an algorithm based on data culled from more than 4,000 malignant and benign lesions, according to the company.

"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," the FDA said, adding that DermaSensor is for use in patients ages 40 and up.

Along with helping to spot melanoma, the most deadly form of skin cancer, the device can also assess moles for basal cell carcinoma and squamous cell carcinoma.

One in five Americans will have developed a form of skin cancer by the age of 70, according to the American Academy of Dermatology, which puts the cost of treatment in the United States at more than $8 billion. Most skin cancers are curable if detected early.

The FDA added that it is requiring additional validation testing in patients from representative demographic groups, including those who are at lower risk of skin cancer.

More information

The Skin Cancer Foundation has more on skin cancer.

SOURCE: U.S. Food and Drug Administration, news release, Jan. 16, 2024; DermaSensor Inc., news release, Jan. 17, 2024