Mela Sciences has received CE Mark approval for MelaFind, a handheld diagnostic imaging device for the early detection of skin cancer.
The company initially intends to market in Germany, which has the highest incidence of melanoma in Europe.
The new scope is designed to help dermatologists gain more accuracy in evaluating abnormal skin moles in order to identify melanoma.
The non-invasive MelaFind technology acquires and displays multi-spectral digital images of pigmented skin lesions and uses automatic image analysis to help spot lesions less than 2.2cm in diameter, which can then be considered for biopsy.
The approval is based on data gathered from a pivotal trial involving 1,383 US patients, demonstrating 98% accuracy.
There is currently no cure for advanced melanoma, but it is virtually 100% curable if detected early.
Melanoma rates in Germany have doubled over the last decade and the national mortality rate from the disease is the highest in Europe. More than 20,000 Germans are expected to be diagnosed with melanoma by 2016.
Dr Joseph Gulfo, President and CEO of Mela Sciences, said: “With more than 81 million people, Germany represents a significant opportunity for the company and an ideal market to launch MelaFind in the EU.”
Shares in the company rose by 70% following the European approval, which has led to hopes that the device will soon be approved in the US. Mela previously submitted a PMA application to the FDA for MelaFind in June 2009, but is still awaiting the Agency’s decision.
Based in New York, Mela Sciences specialises in dermatology and developing devices to aid in the early detection of melanoma.