FDA’s response to ProUroCare Medical Anticipated on February 23 (OTC:PUMD)
On November 23, 2009, ProUroCare Medical Inc. (OTC:PUMD) , (OTC:PUMDU) and (OTC:PUMDW), which discovers, develops and markets novel products for medical imaging, disclosed to its stockholders that it has submitted a 510(K) application to the United States of America’s Food and Drug Administration (FDA) to get the regulator’s approval to market its prostate mechanical imaging system in the United States. It usually takes the FDA about 90 days to review the 510(K) submission. As a result we anticipate ProUroCare Medical to get the FDA’s response to its submission on February 23, 2009.
@@CalendarLeft@@ The prostate mechanical imaging system has been discovered and developed by ProUroCare Medical. As claimed by its labeling, the medical product is capable of helping in the process of taking images of the abnormalities in the prostrate and then recording the images. The prostrate medical imaging system must work with digital rectal examination (DRE) which detects and monitors the abnormalities.
ProUroCare Medical has developed the system using its innovative tactile elasticity imaging technology – whose patent it holds. The technology allows the system to record an image – or “map†– of the affected organ (prostrate). It also lets the system to record the image electronically. This recorded image can then be used for study by physicians in the future.
Rick Carlson, who is the Chief Executive Officer of ProUroCare Medical, 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 createreal-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.â€

By John McCalister on 02/22/2010 2:26 pm PST -- Biotech