Bering Limited, a London-based medical AI company, announces that it received U.S. FDA 510(k) clearance for its AI-powered chest X-ray triage solution, BraveCX. With the FDA clearance, the company is now able to commercially provide the AI solution to medical professionals and healthcare institutions in the U.S.

Bering’s BraveCX is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray (CXR) images for the presence of pre-specified suspected clinical findings. The product was designed to triage and prioritize emergency cases, such as pleural effusion and pneumothorax, immediately after the exam. Findings are notified to the physician, providing a “second opinion” and reducing the time-to-diagnosis of urgent cases.

The product was developed on over 1,000,000 CXRs acquired across diverse clinical settings and further finetuned with more than 50,000 CXRs labeled by board-certified radiologists. BraveCX shows performance of 95%-97% specificity and receiver operating characteristic areas under the curve of 0.96 and 0.98 on pleural effusion and pneumothorax, respectively.

Bering officials say the FDA clearance allows the company to accelerate its sales expansion in the US market. Using a flexible deployment model of a cloud-based service, directly on premises, or integrated with CXR hardware systems, Bering can leverage new and existing partnerships to bring this device to market.

“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,” adds Ignat Drozdov, MD, PhD, CEO and founder of Bering. “FDA clearance means BraveCX prioritizes patient safety while still delivering the most advanced risk stratification algorithms where they are needed the most.”