Prostate imaging developer ProUroCare Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ProUroScan prostate mechanical imaging system.
The ProUroScan system constructs 2D and 3D color maps of the prostate that, when in agreement with a digital rectal exam, can be permanently stored in a patient's electronic medical record. Its tactile elasticity imaging technology uses a handheld pressure-sensing rectal probe and image construction software to produce prostate maps that are distinct from traditional ultrasound imaging, according to the company.
ProUroCare Medical said it plans to introduce the product this year in selected major metropolitan markets.
