ProUroCare Medical files 510(k) application for prostate mechanical imaging system

ProUroCare Medical Inc. announced today 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 system incorporates the company’s unique and patented tactile elasticity imaging technology that creates a “map” of the prostate and an electronic record that can be stored for future analysis.
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.
ProUroCare Medical Inc. (OTCBB: PUMD) (OTCBB: PUMDU) (OTCBB: PUMDW) is a provider of proprietary medical imaging products.