![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Imagen’s Aorta-CAD X-Ray Analysis Device Cleared
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.
Upcoming Events
-
11Jul
-
18Jul
-
21Oct