London-based medical AI company Bering Limited has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its BraveCX AI-powered chest x-ray triage software.
BraveCX is a computer-assisted triage and notification software that analyzes adult (≥ 18 years old) chest x-rays for the presence of prespecified suspected findings. The product was developed on over 1 million chest x-rays and has yielded an area under the curve of 0.96 for pleural effusion and 0.98 for pneumothorax in testing, the company said.