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FDA Authorizes AI-Powered Device DermaSensor for Skin Cancer Detection

The handheld device, designed to assist doctors in evaluating suspicious skin lesions, can detect all three common types of skin cancer.

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Overview

  • The FDA has authorized the use of DermaSensor, an AI-powered handheld device that helps doctors detect skin cancer.
  • The device uses AI-powered spectroscopy technology to assess cellular and below-the-skin's-surface characteristics of lesions on a patient's skin.
  • DermaSensor can detect all three common types of skin cancer—basal cell carcinoma, squamous cell carcinoma and melanoma.
  • The device is intended to be used on lesions already assessed as suspicious for skin cancer and should not be the only diagnostic criterion.
  • The FDA is requiring that DermaSensor conduct additional post-market clinical validation performance testing of the device across demographic groups.