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FDA clears AI-powered chest X-ray triage solution from Bering

by John R. Fischer, Senior Reporter | December 11, 2023
Artificial Intelligence X-Ray
BraveCX (Photo courtesy of Bering)
British AI company Bering Limited has nabbed 510(k) clearance for its AI-powered chest X-ray triage solution, BraveCX, which is designed to identify pleural effusion, pneumothorax and other life-threatening conditions from chest X-rays in patients and triage and prioritize cases based on criticality.

The radiology-based computer-assisted triage and notification software is trained on over one million chest X-rays captured in different clinical settings. Bering added another 50,000 scans labeled by board-certified radiologists to further improve its accuracy and ensure the algorithm's performance aligns with expert radiologist interpretations.

Bering says it is meant to provide a “second opinion” to physicians to help them make clinical decisions quicker and reduce time-to-diagnosis in urgent cases.

"FDA clearance means BraveCX prioritizes patient safety, whilst still delivering the most advanced risk stratification algorithms where they are needed the most,” said Dr. Ignat Drozdov, CEO and founder of Bering, in a statement.

In trials, BraveCX showed 95%-97% specificity and Area under the Receiver operating characteristic (ROC) Curve (AUC) performances of 0.96 for pleural effusion and 0.98 for pneumothorax. Results are made available in under 10 seconds with no additional applications required, and the AI models perform quality control checks to validate that all images meet inclusion criteria.

The company will deploy the solution with a cloud-based service that will make it directly available on premises or integrate it with chest X-ray hardware systems. It also will use existing and seek out new partnerships to increase sales of the product.

Based in London, Bering was founded in 2010 and designs clinical decision-support solutions. Its other products include Brave AI, which uses machine learning to integrate and assess health and social care data for population health management; Brave NGT, an AI-powered software for detecting nasogastric tube malpositions on chest X-rays to help physicians determine if feeding can be safely performed in patients; and CDrift, an autonomous Concept Drift detection service that identifies unforeseen changes in real time in input data for AI models to assess, and alerts production systems with a highly configurable application program interface.

Physicians may only use BraveCX to analyze scans for patients who are 18 and older.

BraveCX is only available for sale in the U.S.

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