FDA grants 510(k) clearance to chest X-ray triage software

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The FDA has granted 510(k) clearance to the artificial intelligence (AI)-based BraveCX chest X-ray triage and notification software. The tool can help clinicians identify certain clinical findings in adults.

BraveCX (Bering Limited) finds prespecified suspected conditions, like pleural effusion and pneumothorax, using chest X-ray images. It can provide a much-needed approach for prioritizing urgent care cases.

According to a BraveCX press release, the software was created based on more than 1 million chest X-rays from a range of clinical settings. Over 50,000 X-rays labeled by radiologists helped the developers adjust and improve BraveCX. 

The software identified pleural effusion and pneumothorax 95% to 97% of the time as well as the operating characteristic area under the curve for both conditions.

The software has been in development for over three years, leveraging research and collaboration with clinical teams, according to BraveCX.  

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