Navigation Links
ProUroCare Medical Announces Filing of Request to Classify the Prostate Mechanical Imager ("PMI") as a Class II Device

MINNEAPOLIS, May 24 /PRNewswire-FirstCall/ -- ProUroCare Medical, Inc. (OTC Bulletin Board: PUMD, PUMDU and PUMDW), a provider of proprietary imaging products, today announced that a meeting was held with the FDA on May 19th to review the 510(k) application for the Prostate Mechanical Imaging (PMI) system, also known as the ProUroScan™ system, and to discuss the requirements for filing a reclassification request (a de novo filing) in accordance with Section 513(f)(2) of the Federal Food, Drug and Cosmetic Act.  On May 21st, a de novo application was filed with the FDA for the ProUroScan (PMI) system.

Following the filing of the initial 510(k) application for the PMI system, the FDA issued a letter stating that the PMI system was not "substantially equivalent" to currently marketed devices.  As required by the Section 513(f)(2) guidance document, a submission was made on May 19th 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.  

The primary benefit of a de novo filing is that it will allow the agency to review and potentially classify mechanical imaging devices, like the ProUroScan, as a Class II device subject to special controls.  Once cleared, the PMI 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).

"The FDA meeting was very productive and the agency indicated a willingness to work with us on the review of the de novo filing," said Rick Carlson, CEO of ProUroCare.  

About ProUroCare Medical, Inc.

ProUroCare Medical, Inc. is a publicly traded company engaged in the business of creating innovative medical imaging products. The company's current focus is the ProUroScan prostate imaging system, which is used to map abnormalities of the prostate detected by DRE. Based in Minneapolis, Minn., ProUroCare is traded on the OTCBB.

Safe Harbor Statement

This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of ProUroCare's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause ProUroCare's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of ProUroCare to find adequate financing to complete the development of its products; the high level of secured and unsecured debt incurred by ProUroCare; the dependence by ProUroCare on third parties for the development and manufacture of its products; and other risks and uncertainties detailed from time to time in ProUroCare's filings with the Securities and Exchange Commission including its most recently filed Form 10-K and Form 10-Q. ProUroCare undertakes no duty to update any of these forward-looking statements.

SOURCE ProUroCare Medical, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. ProUroCare Medical Inc. Announces Pricing of Equity Offering
2. ProUroCare Medical Completes Clinical Trial at Second Study Site Using Digital Prostate Imaging Technology
3. ProUroCare Medical Completes Multiple Site Clinical Study for Imaging Prostate Abnormalities
4. ProUroCare Medical Elects Two New Directors
5. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
6. You May Have a Thyroid Problem and Not Know It - Particularly If Youre Over 60, Says a New Harvard Medical School Report
7. Harvard Medical School-Partners HealthCare Center for Genetics and Genomics Successfully Completes Evaluation of AutoGenomics 2C9-VKORC1 Panel to Assess Warfarin Sensitivity
8. Globus Medical Raises $110 Million in Series E Financing Round
9. Quark Pharmaceuticals Appoints New Chief Medical Officer
10. Boston University Biomedical Engineers Find Chink in Bacterias Armor
11. Rochester Medical Anti-Infection Foley Catheter Demonstrates Effectiveness in Randomized Trial
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... 24, 2016 The Academy of Managed Care ... that would allow biopharmaceutical companies to more easily ... make formulary and coverage decisions, a move that addresses ... medicines. The recommendations address restrictions in the ... the drug label, a prohibition that hinders decision makers ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... "The World Market for Companion Diagnostic Tests" report to ... World Market for Companion Diagnostics The World ... diagnostic and personalized medicine diagnostics. Market analysis in the report ... Diagnostics Test Market (In Vitro Diagnostic Kits) by Region (N. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health ... of their exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards ... at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... Those ... deal with these feelings, many turn to unhealthy avenues, such as drug or alcohol ... of Marne, Michigan, has released tools for healthy coping following a traumatic event. , ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
Breaking Medicine News(10 mins):