MelaFind diagnostic tool
Friday December 2, 2011
FDA grants pre-market approval to MelaFind
In November the US Food and Drug Administration granted premarket approval to MelaFind, a diagnostic tool for melanoma developed by Mela Sciences in the United States. According to the FDA, MelaFind is an “optical imaging and analysis device used in the detection of melanoma among typical skin lesions”. It “uses light to image the skin through a layer of isopropyl alcohol to generate a positive or negative result based on predefined image analysis algorithms”.
An associated media article explains that the device's handheld attachment, about the size of a blow dryer, emits light that penetrates below the surface of the skin, taking multicoloured images that reflect the depth and shape of skin growths. A computer compares these to a database of 10,000 archived images and recommends whether a biopsy should be done.
According to the FDA letter of approval to the manufacturer, “the tool is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of melanoma”.
The FDA also identifies potential adverse effects for MelaFind that are associated with incorrect test results or result interpretations. These include incorrect diagnoses and improper patient management decisions. Furthermore, according to the FDA, false negative results may lead to delays in the timely diagnosis of melanoma and treatment; false positive results could lead to patients unnecessarily undergoing more frequent screening and potentially invasive procedures such as a skin biopsy
According to the FDA, MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind.
The sale and distribution of the device are restricted to prescription use.
Sources:
FDA approval overview
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm280864.htm
FDA approval letter
http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090012a.pdf
MelaFind, device that screens for melanoma with light, approved by FDA
http://www.huffingtonpost.com/2011/11/02/melafind-device-that-scre_n_1071451.html
See also:
MelaFind for Melanoma Detection: Will it Change Practice?
Graeme M. Lipper, MD
Posted: 01/09/2012
http://www.medscape.com/viewarticle/756436?src=mp&spon=17
