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.

Our goal is to have the ProUroScan System regulated by the FDA as a Class II device.  To obtain Class II status, applicants must demonstrate that their device is substantially equivalent to an existing approved product, or "predicate device" in a 510(k) application.  An otherwise safe and effective product that employs such new or novel technology that a predicate device does not exist can still be cleared for marketing using a clearance path that is sometimes referred to as a "de novo"  application.

During 2008 and 2009, our research and development activities conducted through Artann were primarily directed toward completion of the final configuration of the ProUroScan System and conducting clinical trials.  This work culminated in the preparation and submission to the FDA of a 510(k) application in November 2009.  From that submission, the FDA determined that the ProUroScan System is not substantially equivalent (NSE) to a device currently being marketed.  As required by Section 513(f)(2) of the Food, Drug and Cosmetic Act, a submission was made on May 19, 2010 to request 510(k) clearance under the de novo process.  This request asked the FDA to define mechanical imaging systems as devices that are intended to produce an elasticity image of the prostate as an aid in documenting abnormalities of the prostate that are initially identified by digital rectal examination and to be used by physicians as a documentation tool. 

The de novo submission also recommended that the classification regulation state that a "mechanical imaging system" device consists of a trans-rectal probe with pressure sensor arrays and a motion tracking system that provides real time images of the prostate.  These proprietary components are unique to the ProUroScan system. 

Once cleared, the ProUroScan may serve as a predicate for future filings and expanded indications for use.  The time allowed for review of the de novo application is defined by statue under Section 513(f)(2).

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