Densitas Inc. has received U.S. Food and Drug Administration (FDA) clearance for its DENSITAS|density automated breast density software. The software analyzes the same processed digital mammograms that radiologists view and are routinely stored in picture archiving and communication systems (PACS).
Densitas Inc. announced it has received 13485:2003 certification from the International Standards Organization (ISO). This ISO standard specifies the requirements for comprehensive quality management systems for the design and manufacture of medical devices. Densitas is an early stage start-up company that develops software for use in the digital mammography enterprise.
A new research technology was profiled during scientific sessions at the European Congress of Radiology (ECR) in Vienna, Austria. Densitas Research Edition assesses mammographic breast density using ‘for presentation’ digital mammography images.