The US Food and Drug Administration has granted (FDA) 510(k) clearance to Bering Ltd’s artificial intelligence (AI)-powered chest X-ray triage solution, BraveCX, designed to triage and prioritize emergency cases such as pleural effusion and pneumothorax immediately after the exam.
BraveCX is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected clinical findings. Findings are notified to the physician, providing a “second opinion” and reducing the time-to-diagnosis of urgent cases, according to a release from London-based Bering.
The product was developed on over 1,000,000 chest X-rays acquired across diverse clinical settings and further fine-tuned with over 50,000 chest X-rays labeled by board-certified radiologists. BraveCX shows performance of 95%-97% specificity and ROC AUCs of 0.96 and 0.98 on pleural effusion and pneumothorax respectively.
With the FDA clearance, the company is now able to commercially provide the AI solution to medical professionals and healthcare institutions in the US.
“After over three 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,’” says Ignat Drozdov, MD, PhD, CEO and founder of Bering, in a release. “FDA clearance means BraveCX prioritizes patient safety, whilst still delivering the most advanced risk stratification algorithms.”
Photo caption: Demo image of BraveCX
Photo credit: Bering Ltd
