FDA Clears AI-Powered Non-Invasive Skin Cancer Detector

The FDA cleared an artificial-intelligence (AI)-powered device designed to non-invasively detect skin cancer in the primary care setting, the agency announced on Tuesday.

Developer DermaSensor said the device uses AI-powered spectroscopy technology to non-invasively evaluate cellular and subcellular characteristics of a lesion for any of the three common skin cancers — melanoma, basal cell carcinoma, and squamous cell carcinoma. The wireless, handheld device then provides a result in real time using an FDA-cleared algorithm.

The device was evaluated in a study of 1,005 patients across 22 centers that showed the device had a 96% sensitivity in detecting skin cancers, while a negative result had a 97% chance of being benign for all skin cancers.

A companion clinical utility study with 108 physicians, found that use of the device decreased the number of missed skin cancers by half (from 18% to 9%).

According to the FDA, the device — which will be available by prescription — is indicated for the evaluation of skin lesions in patients 40 years and over, and to assist health care providers in determining whether to refer a patient to a dermatologist.

The device should be used on lesions already assessed as suspicious for skin cancer, the agency said, and not as a screening tool, nor as the sole diagnostic criterion or to confirm a diagnosis of skin cancer.

“The benefits are as much for dermatologists as they are for [primary care physicians],” the company said in a release. “DermaSensor is expected to improve primary care and dermatology collaboration, enabling better-prioritized referrals in addition to the referral of more patients with skin cancer.”

The FDA is requiring that the company conduct additional post-market clinical validation performance testing of the DermaSensor device in patients representative of the general population, including people who had limited representation of melanomas in the premarket studies.

Mike Bassett is a staff writer focusing on oncology and hematology. He is based in Massachusetts.

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