The solution, dubbed BraveCX, is a radiological computer-assisted triage and notification software designed to analyse adult chest X-ray (CXR) images to detect pre-specified suspected clinical findings, to triage and prioritise emergency cases immediately after the exam
Bering secures FDA approval for BraveCX. (Credit: CDC on Unsplash)
UK-based medical AI company Bering has secured the US Food and Drug Administration (FDA) 510(k) approval for its AI-powered chest X-ray triage solution, BraveCX.
BraveCX is a radiological computer-assisted triage and notification software that analyses adult chest X-ray (CXR) images to detect pre-specified suspected clinical findings.
The device is designed to triage and prioritise emergency cases such as pleural effusion and pneumothorax immediately after the exam.
Its findings are notified to the physician, providing a second opinion and reducing the time-to-diagnosis of urgent cases, said the medical device company.
Bering CEO and founder Ignat Drozdov said: “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 prioritises patient safety, whilst still delivering the most advanced Risk Stratification algorithms where they are needed the most.”
BraveCX was developed using more than 1,000,000 CXRs acquired across diverse clinical settings and is further fine-tuned with more than 50,000 CXRs labelled by certified radiologists.
The device performs with a superior specificity of 95% to 97%, and ROC and AUCs of 0.96 and 0.98 on pleural effusion and pneumothorax, respectively.
It can be easily deployed through a cloud-based service model, directly on-premises, or integrated with CXR hardware systems.
Bering is planning to use new and existing partnerships to bring the AI X-ray triage device to the market.
The FDA approval allows the company to start commercialising the BraveCX solution to medical professionals and healthcare institutions in the US.