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FDA Clears Handheld Device to Assist PCPs in Skin Cancer Detection

The FDA has cleared the DermaSensor device, a noninvasive point-of-care skin cancer evaluation system.

FDA clears AI-powered handheld that checks moles for skin cancer

FDA clears AI-powered handheld that checks moles for skin cancer
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FDA clears DermaSensor AI-powered skin cancer detection device

DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.

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

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.

FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers (Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma)

FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers (Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma)
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