Regulatory News: Siemens gets FDA approval letter for lung CAD device

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Siemens Medical Solutions received premarket approval letter from the FDA for its syngo Lung CAD device, which is designed to assist radiologists in the detection of solid lung nodules in CT examinations of the chest. syngo Lung CAD was validated on the use of CAD in thoracic CT examinations in a large multi-center, multi-reader study. Each of the nearly 200 cases was reviewed by 17 radiologists using data from four medical centers in the United States. The use of syngo Lung CAD as a second reader helped all participating radiologists to increase their detection accuracy for clinically significant lung nodules, the company says.