FDA approves ProUroScan (ProUroCare Medical) for elasticity imaging of the prostate

The FDA has given 510(k) approval for the ProUroScan prostate mechanical imaging (PMI) system, from ProUroCare Medical. ProUroScan is an advanced medical elasticity imaging system that uses an array of ultrasonic sensors mounted on a rectal probe, a central processing unit and software and image construction algorithms to provide a real time color image of abnormalities in the prostate. It constructs colour 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. The company plans to introduce the technology in 2012 to a limited number of US medical care centers in major metropolitan markets.