Parascript AccuDetect 7.0 Mammography Computer-Aided Detection Approved by FDA

November 13, 2015 — The U.S. Food and Drug Administration (FDA) has approved Parascript AccuDetect 7.0 for mammography systems manufactured by General Electric, Philips, Hologic, Fujifilm, Carestream, IMS and Planmed.

The software is also CE marked and, in addition to the manufacturers listed above, it is compatible with digital radiography (DR) and computed radiography (CR) mammography systems from Agfa Healthcare, Allengers Medical Systems and Siemens.

AccuDetect is computer-aided detection (CAD) for mammography. It uses multiple independent cancer detection algorithms and a patented voting methodology to combine its findings. Comparing the results of the multiple image recognition processes allows for the mitigation of the inherent faults of the recognition processes, thus leading to improved sensitivity and reduced false-positive rates.

Per the study results published in Clinical Imaging (M. Lobbes et al., Clinical Imaging 37 (2013) 283-288) regarding the previous version of AccuDetect CAD, the system has shown better overall performance when compared to iCAD’s Second Look in detecting both soft tissue densities and calcifications. When compared to Second Look in extremely dense breasts (ACR 4), AccuDetect demonstrated a 15.4 percent increase in detection of both masses and calcifications, and a 14.6 percent increase in total cancer cases detection.

For more information: www.parascript.com