For use in visualising and documenting abnormalities of the prostate detected and/or monitored by digital rectal examination
ProUroCare Medical has filed 510(k) application for US market clearance of a prostate mechanical imaging system with the FDA. The labeling claim for the device is that it can be used as an aid to visualise and document abnormalities of the prostate detected and/or monitored by digital rectal examination (DRE).
The company said that under the 510(k) review process, the FDA has 90 days to review the application, although final approval may take longer.
The system incorporates the company’s patented tactile elasticity imaging technology that creates a map of the prostate and an electronic record that can be stored for future analysis.
The company added that the prostate imaging system’s 510(k) was supported by the results of a recently completed clinical study of 56 patients evaluated at five US medical centers, and an earlier study of 168 patients at the Robert Wood Johnson Medical Center, New Brunswick, New Jersey.
Reportedly, the studies were conducted by ProUroCare’s development partner Artann Laboratories, with the support of a $3m grant provided by the National Institute of Health and the National Cancer Institute.
Rick Carlson, CEO of ProUroCare, said: “The filing of the 510(k) application for the prostate imaging system is an important milestone for us and is the culmination of several important projects and initiatives completed over the past two years. We are excited about the system’s demonstrated ability to create real-time images that can be used by physicians to help identify abnormalities in the prostate.
“The response of physicians who participated in these clinical studies has been extremely positive; several have expressed interest in pursuing follow-on studies to validate the use of our innovative and proprietary technology for additional clinical indications.”