The Food and Drug Administration has authorized the first artificial intelligence-powered medical device to help doctors detect the most common forms of skin cancer in patients.
The technology, from Miami-based medical device maker DermaSensor, is used to further evaluate lesions that doctors have already flagged as suspicious and is not meant to be used as a screening tool, according to the FDA.
More specifically, the non-invasive, handheld device uses AI-powered spectroscopy tech to assess cellular and below-the-skin’s-surface characteristics of lesions on a patient’s skin. The device, also called DermaSensor, provides real-time results based on an AI algorithm that is trained on data related to more than 4,000 malignant and benign lesions, according to the company. It then delivers a “spectral similarity score” to known cases in order to complement a physician’s own assessment of a mole or lesion.
DermaSensor says the device gives primary care physicians, dermatologists and other doctors a high-tech way to evaluate moles for skin cancer beyond simply beyond examining a patient with the naked eye or using a magnifying glass.
“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, noting that DermaSensor is for use in patients ages 40 and up.
Here’s how DermaSensor works, according to the company.
1. A doctor identifies a potentially cancerous lesion on a patient.
2. The wireless device is against the lesion to record it.
3. DermaSensor scans the lesion.
4. A proprietary algorithm analyzes spectral data and delivers an assessment in real-time.
5. An “Investigate Further” result suggests a specialist should examine the lesion.
6. A “Monitor” result suggests no further evaluation is immediately necessary.
“We are entering the golden age of predictive and generative artificial intelligence in health care, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care,” Cody Simmons, co-founder and CEO of DermaSensor, in a statement announcing the FDA clearance.
In addition to helping spot melanoma, which is 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 cumulative cost of treatment in the U.S. at more than $8 billion. Most skin cancers are curable if detected early.
In approving the DermaSensor device, the FDA is requiring that the company conduct additional validation testing in patients from broadly representative demographic groups, including those who are at lower risk of skin cancer.