Melanoma detection device receives FDA pre-market approval

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Melanoma detection device receives FDA pre-market approval

The AP reports, “Dermatologists will soon get some high-tech help deciding which suspicious-looking moles should be removed and checked for melanoma, the deadliest form of skin cancer.” Last month, the Food and Drug Administration (FDA) “approved a first-of-its-kind device, called MelaFind, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists.”
MedPage Today reports that the “computer-assisted melanoma diagnostic tool … has received FDA pre-market approval (PMA) for use on atypical cutaneous pigmented lesions.”
Specifically, “the device is indicated only for use on lesions that meet a number of specific criteria, including:

  • accessibility by MelaFind tool;
  • diameter of 2 to 22 mm;
  • sufficient pigmentation;
  • no scarring or fibrosis;
  • non-ulcerous and nonbleeding;
  • not on acral, palmar, plantar, mucosal, or subungual areas; [and]
  • located >1 cm from eyes.”

And, “according to the agreed-upon labeling, ‘MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy'” and “should NOT be used to confirm a clinical diagnosis of melanoma.”
The device “includes a handheld scanner and a computer program that analyzes images of skin lesions.
In a clinical trial, the device missed only 2% of biopsy-proven melanomas,” WebMD reports.
“However, the device had a high false-positive rate. About 90% of the time, lesions identified as suspicious by the MelaFind device turned out not to be melanoma. But in the same clinical trial, a panel of dermatologists who did not use the device had an even higher false-positive rate.”

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