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ProUroCare Medical files marketing application for new prostate imaging system

Posted on: Thu, 26 Nov 2009 05:12:00 EST

Symbols: PUMDU

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Nov 26, 2009 (Datamonitor via COMTEX) --
PUMDU | Quote | Chart | News | PowerRating -- ProUroCare Medical, a provider of medical imaging products, has filed a 510(k) application with the FDA for US market clearance of a prostate mechanical imaging system.

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. Under the 510(k) review process, the FDA has 90 days to review the application, although final approval may take longer.

The system incorporates the company's patented tactile elasticity imaging technology that creates a 'map' of the prostate and an electronic record that can be stored for future analysis, said ProUroCare Medical.

Rick Carlson, CEO of ProUroCare, said: "The filing of the 510(k) application for the prostate imaging system is an important milestone for us and is the culmination of several important projects and initiatives completed over the past two years. We are excited about the system's demonstrated ability to create real-time images that can be used by physicians to help identify abnormalities in the prostate.

"The response of physicians who participated in these clinical studies has been extremely positive; several have expressed interest in pursuing follow-on studies to validate the use of our innovative and proprietary technology for additional clinical indications."

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