Shares of Mela Sciences Inc. soared 55 percent Monday after it announced it is one step closer to final government approval for a medical device meant to help dermatologists in the process of diagnosing skin cancer.
Shares closed at $4.95, up from $3.18. The stock has been volatile as the company waits for final approval for its device. Shares have been climbing fairly steadily since a low of $1.75 on Aug. 10, but they're still down from highs of more than $8 last October.
The company, based in Irvington, N.Y., said Monday the Food and Drug Administration has issued an "approvable letter" that will allow Mela to move forward with creating labeling, training programs and other materials for MelaFind.
MelaFind, the company's flagship product, is a handheld device that uses lights of different wavelengths to create images of a mark on the skin. It is not meant to diagnose melanoma or other skin cancers, but to help doctors determine whether to proceed with a biopsy.
MelaFind already has been approved for sale in the European Union.