FDA Approves AccuDetect® 7.0 Expanding Parascript’s Reach

Longmont, CO – 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.

AccuDetect is also CE marked and, in addition to the manufacturers listed above, it is compatible with Direct Radiography (DR) and Computed Radiography (CR) mammography systems from Agfa Healthcare, Allengers Medical Systems, and Siemens.

AccuDetect is Computer-Aided Detection (CAD) for mammography. AccuDetect uses multiple independent cancer detection algorithms and a unique 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 15.4 percent increase in detection of both masses and calcifications, and 14.6 percent increase in total cancer cases detection.

“Approval of AccuDetect 7.0 provides more options for patients, especially patients with dense breasts,” said Dr. Alexander Filatov, CEO and President at Parascript. “Despite progress over the past few decades, early detection of breast cancer remains a leading concern in the U.S. and globally.”

About Parascript, LLC

Parascript automates the extraction of meaningful, contextual data from image and document-based information to support medical imaging, as well as transactions, information governance, fraud prevention, and business processes. Parascript software processes any document with any data from any source with its easy-to-use, image-based analysis, classification, data location, and extraction technology. More than 100 billion documents for financial services, government organizations, and the healthcare and life sciences industry are analyzed annually by Parascript software. Our OEM and value-added reseller network partners integrate and distribute Parascript software in the US and across the world. Visit Parascript online.