ProUroCare Medical Inc. announced it has received clearance from the U.S. Food & Drug Administration for its ProUroScan(TM) prostate mechanical imaging system. The approval paves the way for men and their families to receive high-resolution visual documentations as an aid in detecting prostate abnormalities that were previously detected by digital rectal examination. The ProUroScan system constructs color 2D and 3D "maps" of the prostate in real-time that, when in agreement with a DRE finding, can be permanently stored in electronic records for future analysis and comparison. ProUroCare's patented tactile elasticity imaging technology, which uses a handheld pressure-sensing rectal probe and sophisticated image construction software to produce its prostate maps, represents a new imaging modality distinct from traditional ultrasound imaging. The company plans to introduce the technology in 2012 to a limited number of top U.S. medical care centers in key major metropolitan markets. With assistance from Minneapolis investment firm Cherry Tree & Associates, LLC, ProUroCare has been actively seeking a strategic corporate partner with a strong sales and in-service support presence in the urologic market to fully commercialize its technology. As a standard of care, 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% predictive value. 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. 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.