Medical device company SciBase said today it won FDA pre-market approval for its Nevisense device designed for the early detection of malignant melanoma.
The Stockholm-based company’s device is indicated for use on cutaneous lesions with 1 or more clinical or historical characteristics of melanoma, for obtaining additional information when considering a biopsy, the company said.
The Nevisense device is designed to detect malignant melanoma, the deadliest form of skin cancer which accounts for 75% of deaths related to skin cancer, directly on the skin, SciBase said. The company touted the device as the 1st of it’s kind on the US market.
“Most employees in the company have been working directly or indirectly on the approval for many years, and this really is a remarkable and nearly unique achievement given the size of our company. It’s no secret that the US market is the world’s largest and most profitable market for medical devices and in the long term, it represents a huge growth potential for us,” CEO Simon Grant said in a prepared statement.
SciBase said that with the approval, it will accelerate its activities and prepare for a US launch sometime after summer.