FDAnews Device Daily Bulletin

LIFELINE BIOTECHNOLOGIES FILES 510(K) APPLICATION WITH THE FOOD AND DRUG ADMINISTRATION FOR THE MASTASCOPE

Nov. 18, 2005
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Lifeline Biotechnologies recently announced that the Company has filed a 510(k) Pre-market Notification with the FDA, for the MastaScope product line. The FDA approval process is expected to take several months to complete. The MastaScope is a microendoscope that is utilized by physicians to observe the interior of women's breast milk ducts when examining for abnormalities, in particular, nipple discharge. The majority of breast cancers originate in the milk ducts. It is anticipated that this product and process of examination, will assist in the early detection of breast cancer and holds the prospect of reducing unnecessary exploratory surgeries.
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