Prostate Imaging System Receives FDA Approval
The FDA has approved the use of ProUroScan, a prostate mechanical imaging system that creates high-resolution visual documentation to better aid in the detection of prostate abnormalities.
The device works by constructing 2D and 3D color maps of the prostate in real-time when following up on a digital rectal examination (DRE). This allows for permanent storage of electronic records for future analysis and comparison.
Current prostate cancer screening recommendations from American Urological Association suggest offering patients a DRE and PSA blood test beginning at age 40. This only has a 56% positive predictive value for prostate cancer. ProUroScan will be able to more effectively diagnose and treat abnormalities following a suspicious DRE, according to a press release issued by the company.
ProUroScan was developed by ProUroCare Medical Inc. of Minneapolis, Minn.