This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: M-Vu Algorithm Engine

PMA Applicant: VuCOMP, Inc.

Address: 2500 North Dallas Parkway, Suite 500, Plano, Texas 75093

Approval Date: January 23, 2012

Approval Letter:

What is it? The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to help radiologists read routine screening mammograms.

How does it work? The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed on either a computer monitor or printout.

When is it used? Radiologists will use the software in their clinical offices when reading routine screening mammograms. The radiologist first reads each image in the conventional manner. The radiologist will then re-examine each region marked by the M-Vu Algorithm Engine before making a decision about the image.

What will it accomplish? The M-Vu Algorithm Engine is intended to help radiologists detect breast cancer. In an important clinical study, radiologists were more effective in detecting cancer when using the M-Vu Algorithm Engine as compared to reading the images without the M-Vu Algorithm Engine.

When should it not be used? There are no contraindications.

Additional information: Summary of Safety and Effectiveness and labeling are available online.

Other Resources: