FDA Grants Clearance to Bering's AI-Powered Chest X-Ray Triage Solution

Thursday, December 07, 2023

Bering Limited, a medical AI company based in London, has achieved a significant milestone with the recent clearance from the US Food and Drug Administration (FDA) for its AI-powered chest X-ray triage solution named 'BraveCX.' This regulatory approval now allows the company to commercially offer its innovative AI solution to healthcare institutions and medical professionals throughout the United States.

BraveCX, developed by Bering, is described as a radiological computer-assisted triage and notification software designed to analyze adult chest X-ray (CXR) images for predetermined suspected clinical findings. It focuses on addressing emergency cases such as pleural effusion and pneumothorax, providing swift triage and prioritization immediately following the X-ray examination.

The software's primary function is to reduce the time-to-diagnosis for urgent cases by promptly notifying physicians of its findings, essentially offering a "second opinion" to expedite the diagnostic process. The development of BraveCX involved utilizing a substantial dataset comprising over 1,000,000 CXRs from diverse clinical settings, with further refinement through the input of over 50,000 CXRs labeled by board-certified radiologists.

BraveCX has demonstrated commendable performance metrics, with specificity rates ranging between 95% and 97% and Receiver Operating Characteristic (ROC) Area Under the Curves (AUCs) of 0.96 and 0.98 for pleural effusion and pneumothorax, respectively. A noteworthy feature of BraveCX is its deployment flexibility, allowing implementation as a cloud-based service, directly on premises, or integration with CXR hardware systems. This flexibility positions Bering to leverage both new and existing partnerships for a rapid and effective market rollout. With the FDA clearance secured, Bering Limited is now well-positioned to accelerate its sales expansion within the US market. The company's commitment to prioritizing patient safety, combined with the delivery of advanced Risk Stratification algorithms, underscores its dedication to providing cutting-edge AI solutions precisely where they are most needed in the healthcare sector.


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