FDA Clears AI-Powered Device for Detecting Skin Cancer

By Rob Dillard - Last Updated: January 18, 2024

Medical device manufacturer DermaSensor announced this week that the US Food and Drug Administration (FDA) has cleared its handheld artificial intelligence (AI)-based device, which is also called the DermaSensor, for the detection of skin cancer.

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Skin cancer, the most common cancer in the world, is typically identified using dermatoscopy, a procedure in which a medical professional examines the skin for abnormalities associated with skin cancer using a specialized magnifying glass or through a visual examination.

The DermaSensor uses light in concert with an AI-powered algorithm to help physicians identify the presence of cancer in suspicious moles and lesions.

The FDA clearance is based on the findings of a study that demonstrated the DermaSensor showed a 96% sensitivity in detecting skin cancers, while a negative test result had a 97% chance of being benign, according to the company.

Company CEO Cody Simmons said the device, which is currently available in Europe and Australia, will be priced using a subscription model at $199 a month for 5 patients or $399 a month for unlimited use.

 

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