Med Device Monday: MelaFind

According to the Skin Cancer Foundation, the United States will see more than 75,000 new cases of invasive melanoma diagnosed in 2016, and one death from melanoma every 52 minutes. While melanoma accounts for less than 1% of skin cancer diagnoses, it causes the majority of skin cancer deaths. Early detection is key, because if caught early, melanoma can be treated and likely cured. Clearly, a device that aids in early detection and clinical assessment is a welcome device indeed.  

Melanoma can only definitively be diagnosed with a biopsy of the affected area - which usually presents as an irregular looking mole, bump, or lesion. But MelaFind helps doctors make decisions about which moles need to be biopsied earlier than can be done with the naked eye alone. Using infrared light, the scanner is held over an irregular looking spot and looks up to 2.5 millimeters below the surface of the skin, where the human eye cannot. It then gives the doctor, who has been trained to use the device, either an all-clear or a recommendation for biopsy. The positive or negative result is based on data and algorithms from the MelaFind database. Per the their website, "MelaFind was developed, trained, and tested on a database of over 10,000 pigmented skin lesions – the largest database of this type. This development process was the foundation of the MelaFind device that dermatologists use in their offices today." In addition to early detection and mortality prevention, MelaFind aids in reducing the number of unnecessary biopsies and their associated costs and resulting scars. 

Watch the videos below for more information. MelaFind's premarket approval (PMA) can be found here and more info from FDA is here. An interesting blurb from the American Society of Mechanical Engineers (ASME) is here

"We have to detect melanoma early to lower mortality. MelaFind helps us achieve that goal because it gives us the additional information to help us be more accurate in our biopsy decisions."