FDA Approves Melanoma Detection Device
// Only cleared by a 8-7 FDAvote.
// Ultimate goal of these devices is to decrease frequency of unnecessary biopsies. I am not sure about this MELA device though, data is not convincing.
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
- Located >1 cm from eyes
(via MedPageToday)
