US FDA clears DermaSensor's AI-powered skin cancer detecting device

[January 18, 2024]  (Reuters) - Privately-held device maker DermaSensor said on Wednesday that the U.S. Food and Drug Administration had cleared its hand-held device that uses artificial intelligence to detect skin cancer.

The Miami-based private company's device - also called DermaSensor - utilizes light and an AI-powered algorithm to help primary care physicians in identifying the presence of cancer in suspicious moles or lesions.

Skin cancer is typically identified through dermatoscopy, a procedure in which a medical professional examines the skin for signs of cancer using a specialized magnifying glass or through a visual examination.

The FDA clearance is based on a study which showed that the device had a 96% sensitivity in detecting skin cancers. A negative result through the device had a 97% chance of being benign, according to the company.

When brought in contact with skin, the device emits light and captures the wavelengths of light reflecting off cellular structures beneath the skin's surface.

It subsequently utilizes an algorithm to analyze the reflected light and detect the presence of skin cancer.

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed/File Photo

Skin cancer is the most common cancer in the world, and its most serious form, melanoma, leads to the death of about 9000 people each year in the U.S.

Company CEO Cody Simmons said the device will be priced through a subscription model at $199 a month for five patients or $399 a month for unlimited use.

DermaSensor is currently commercially available in Europe and Australia.

(Reporting by Christy Santhosh in Bengaluru; Editing by Tasim Zahid)

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