FDA grants 510(k) clearance to chest X-ray triage software

The FDA has granted 510(k) clearance to BraveCX, an artificial intelligence-based chest X-ray triage and notification software that can identify prespecified suspected clinical findings in adults, according to a press release.

BraveCX (Bering Limited) finds prespecified suspected conditions, like pleural effusion and pneumothorax, using chest X-ray images, allowing physicians to prioritize cases that require emergent care.

The release notes that this software was established based on more than 1,000,000 chest X-rays from a range of clinical settings. Over 50,000 X-rays labeled by radiologists helped the developers adjust and improve BraveCX.

The software demonstrated high specificity of pleural effusion and pneumothorax (95%-97%), as well as high receiving operating characteristic area under the curve for both conditions (0.96; 0.98). Both measures signal “excellent performance,” according to the release.

“After over 3 years of research and collaboration with clinical teams, it’s so exciting to see BraveCX emerge as a state-of-the-art tool that has actually ‘listened to the end user,’” Ignat Drozdov, MD, PhD, Bering CEO and founder, said in the release. “FDA clearance means BraveCX prioritizes patient safety, whilst still delivering the most advanced risk stratification algorithms where they are needed the most.”