MINNEAPOLIS--(BUSINESS WIRE)--ProUroCare Medical Inc. (OTCBB: PUMD) (OTCBB: PUMDU) (OTCBB: PUMDW), a provider of proprietary medical imaging products, today announced that a 510(k) application for U.S. market clearance of a prostate mechanical imaging system has been filed with the Food & Drug Administration (FDA). The labeling claim for the device is that it can be used as an aid to visualize and document abnormalities of the prostate detected and/or monitored by digital rectal examination (DRE). Under the 510(k) review process, the FDA has 90 days to review the application, although final approval may take longer.
