www.fdanews.com/articles/179429-qview-medical-get-fda-pma-approval-for-qvcad
QView Medical Get FDA PMA Approval for QVCAD
November 23, 2016
QView Medical has received FDA approval for QVCAD which is a CAD system for automated breast ultrasound (ABUS).
QVCAD presents the CAD results which include a C-thru navigator image and CAD marks indicating regions of interest, in tandem with the original ABUS image.
The QVCAD pivotal reader study submitted in the PMA application demonstrated that QVCAD reduces reader review time while preserving the accuracy of diagnosis. — Cynthia Jessup