FDA Approves First-of-Its-Kind AI-Powered Handheld Device for Skin Cancer Detection

18 Jan 2024 • The US FDA has approved an AI-powered device for non-invasively evaluating skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and over in primary care settings.

  • The device was evaluated in the DERM-SUCCESS study which was led by the Mayo Clinic across 22 study centers and enrolled over 1000 patients.
  • It demonstrated a 96% sensitivity across all 224 types of skin cancers. Further, negative results had a 97% chance of being benign across all skin cancers.
  • A companion clinical utility study also investigated the device's usage with 108 physicians. This study found that the device decreased the number of missed skin cancers by half (18% vs 9%).

The device is to be used in conjunction with clinical assessment and not as a screening tool, nor as the sole diagnostic criterion or to confirm a diagnosis of skin cancer.

Source: FDA | Read full story

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