ProUroScan - Regulatory Status


The ProUroScan prostate elasticity imaging system has been tested in laboratory experiments on prostate models and in a clinical study. The ProUroScan system was studied for over two years and on more than 200 patients at the Robert Wood Johnson Medical Center in New Brunswick, New Jersey. In March 2008, an article authored by Dr. Robert Weiss and Artann scientists and published in the peer-reviewed journal Urology reported that in 84% of the cases in a 168 patient pre-clinical study, the system was able to reconstruct three-dimensional (3D) and 2D cross-sectional images of the prostate.

Based on discussions between our development partner Artann Laboratories Inc. (“Artann”) and representatives from the FDA, we believe that the ProUroScan System with a basic mapping and data maintenance claim will be regulated by the FDA as a class II device. Class II devices typically are cleared for marketing by the FDA through a 510(k) approval process.

We recently completed a multi-site clinical study of the ProUroScan imaging system designed to provide documentation to the FDA of the system's effectiveness in visualizing and documenting abnormalities of the prostate detected by DRE.   A 510(k) application for market clearance of this technology in the U.S. is anticipated to be filed with the FDA in 2009.  Once submitted, the FDA has 90 days to review and grant clearance, ask questions or reject the 510(k) application. However, the 510(k) application process may be significantly longer if the FDA has questions upon its review or requests additional information.

Prostate Health Resources

We are currently exploring potential marketing relationships with medical product companies that are interested in marketing products in the prostate cancer detection market.   We expect such a relationship would provide both We are currently exploring potential marketing relationships with medical product companies that are interested in marketing products in the prostate cancer detection market.   We expect such a relationship would provide both financial support and access to down stream sales, marketing, engineering, manufacturing and regulatory resources. For more information on prostate health resources, click here.

Not available for Sale in the United States.
CAUTION – Investigational device.  Limited by Federal law to investigational use.