ProUroCare Receives FDA 510(k) Clearance for Prostate Imaging System
ProUroCare Medical has announced it has received FDA 510(k) clearance for its ProUroScan prostate mechanical imaging system, according to a news release (pdf).
The company describes the ProUroScan as "an advanced medical imaging system that uses an array of 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."
"This is a major milestone for the company, for physicians looking for more assurance and documentation in their evaluations and for men eager for more information to assess and make decisions about their prostate health," said Rick Carlson, CEO of ProUroCare Medical, in the release. "A color image can go a long way in documenting a person's prostate condition, and this development puts us one step closer to supplementing other screening measures with a helpful, high quality visual aid that can be referred and compared to over time."
ProUroCare Medical is based in Minneapolis.
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