Lifeline files 510(K) with FDA for MastaScope products to detect breast cancer

By E. Janene Geiss

Philadelphia, Nov. 17 - Lifeline Biotechnologies said Thursday that it has filed its 510(K) Pre-market Notification with the U.S. Food and Drug Administration for the MastaScope product line.

The MastaScope is a micrendoscope used by doctors to observe the interior of women's breast milk ducts when examining for abnormalities, particularly nipple discharge, officials said in a news release.

The scope and examination will likely assist in the early detection of breast cancer and may reduce the need and number of exploratory surgeries, officials said. Officials said that for every 100 nipple discharge cases, one instance of breast cancer is found.

"We knew that eventually we would need to complete this 510(K) once the MastaScope advanced from research and development to marketing and sales. We are very excited about the potential future of the MastaScope," Lifeline chief executive officer Jim Holmes said in the release.

The FDA process is expected to take several months, officials said.

Reno, Nev.-based Lifeline Biotechnologies is a medical technology development company.

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