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.
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