FDA market clearance granted to AI-based chest x-ray triage solution

Bering Limited (London, UK) has just achieved a major milestone in medical diagnostics, with the US FDA granting 510(k) clearance for its innovative AI-driven chest x-ray (CXR) triage solution: ‘BraveCX’. This approval brings Bering’s advanced AI solution to the commercial market, reaching medical professionals and healthcare institutions across the US.

BraveCX is a radiological computer-assisted triage and notification software specifically designed for analyzing CXR images of adults 18 years and above. The software efficiently identifies pre-specified inferred clinical findings, enabling immediate triaging and prioritization of emergency cases, including conditions like pleural effusion and pneumothorax, identified immediately after examination. By offering a valuable “second opinion” to physicians, BraveCX significantly diminishes the time-to-diagnosis for urgent cases.

The foundation of this product is deep-rooted in a vast dataset comprising over 1,000,000 CXRs gathered from diverse clinical settings. BraveCX was further refined through the meticulous labeling of over 50,000 CXRs by board-certified radiologists.

And why exactly has this product been the focus of FDA special treatment? Well, BraveCX has outstanding performance metrics, boasting 95%-97% specificity and Receiver Operating Characteristic (ROC) Area Under the Curve (AUC) scores (measures of accuracy for diagnostic tests) of 0.96 and 0.98 for pleural effusion and pneumothorax, respectively.

With the much sought-after FDA clearance now in hand, Bering is poised to expand its market presence in the US. The company offers a versatile deployment model, allowing the utilization of BraveCX through on-premises installations, cloud-based services, or integration with existing CXR hardware systems. Through strategic collaborations with both new and established partners, Bering is positioned to swiftly introduce this revolutionary diagnostic tool to a broader audience.

This market approval marks a significant milestone in the intersection of AI and healthcare, paving the way for enhanced diagnostic capabilities and improved patient outcomes.

Ignat Drozdov, the CEO and founder of Bering, expressed his enthusiasm, remarking, “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’. FDA clearance means BraveCX prioritizes patient safety, whilst still delivering the most advanced Risk Stratification algorithms where they are needed the most.”