FDA approves prostate imaging system

May 16, 2012

ProUroCare Medical Inc. (Minneapolis), has received FDA clearance to market its ProUroScan prostate mechanical imaging system.

ProUroCare Medical Inc. (Minneapolis), has received FDA clearance to market its ProUroScan prostate mechanical imaging system.

ProUroScan offers high-resolution visual documentations as an aid in detecting prostate abnormalities that were previously detected by digital rectal examination, according to the company.

The system constructs color 2-D and 3-D "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 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, ProUroCare says.

"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 Robert Weiss, MD, of the Cancer Institute of New Jersey, New Brunswick, and Robert Wood Johnson Medical School, New Brunswick, NJ, 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."

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