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ProUroCare Medical Receives FDA Clearance for ProUroScan Elasticity Imaging System
Date:5/1/2012

e, the American Urological Association (AUA) currently recommends that beginning at age 40, men receive a DRE and a prostate specific antigen (PSA) blood test in their yearly physical, yet data from community-based studies suggest the positive predictive values of DRE and PSA combined achieve only a 56 percent predictive value.  Furthermore, neither test creates a physical or visual record of the prostate.  The ProUroScan system is being introduced as an adjunctive technology to a DRE for physicians to use to further clarify and document abnormalities associated with the prostate gland. 

"Having a visual aid of irregularities can be so helpful to physicians and patients, particularly in the area of prostate care where decision-making is often difficult," said Dr. Robert Weiss, a urologic oncologist with the Cancer Institute of New Jersey and a faculty member at Robert Wood Johnson Medical School who used the ProUroScan technology as part of its clinical trial process.  "The quality and resolution of the images are excellent, providing an immensely valuable supplement to the DRE, where physicians must rely on a gloved finger to feel for changes in the size and shape of the gland." 

The prostate imaging system's FDA 510(k) was first submitted by ProUroCare's development partner Artann Laboratories, Inc. and later processed in accordance with the de novo provisions accounted for in Section 513(f)(2) of the Federal Food, Drug and Cosmetic Act. The FDA filings were supported by data from a 2009 National Institute of Health and National Cancer Institute-supported clinical study of patients evaluated at five leading U.S. medical centers, as well as an earlier study conducted specifically at the Robert Wood Johnson Medical Center in New Brunswick, N.J.

About ProUroCare Medical Inc.

ProUroCare Medical Inc. is a publicly traded company engaged in the business of creating innovative medical imaging pr
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SOURCE ProUroCare Medical Inc.
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