Imagen’s Aorta-CAD X-Ray Analysis Device Cleared

Imagen Technologies’ Aorta-CAD (computer aided detection) device gained FDA’s 510(k) clearance to detect signs of plaque buildup in the aorta and aortic ectasia, a widening of the aorta, using standard chest X-rays.

The device, which can be toggled off when not in use, creates an annotated overlay that draws attention to potential anomalies.

Results from a clinical trial showed a 62 percent reduction in physician misses of aortic calcification and a 33 percent reduction in misses of dilated aortas, the company said.