New FDA clearances authorize the use of an AI tool to detect lung nodules and help triage pneumothorax and pleural effusion on chest X-rays.
AZmed, specializing in artificial intelligence (AI)-powered medical imaging solutions, has received two new US Food and Drug Administration (FDA) clearances for its AI tool AZchest. The clearances include applications intended to assist radiologists in the interpretation and detection of chest X-rays for lung nodules and triage capabilities for pneumothorax and pleural effusion.
A standalone study on chest X-rays showed that AZchest has extremely high sensitivity in detecting lung nodules, at 88.47%, associated with a high specificity of 82.94%. In a controlled multi-reader multi-case trial, experienced radiologists interpreted a standardized set of chest X-rays both with and without the assistance of AZchest. When aided by AZchest, the sensitivity increased by 10%, reaching 89.35%. The AUC also increased by 5%.
Regarding the triaging of pneumothorax and pleural effusion, the algorithm also confirmed its high detection performance. The sensitivity and AUC for pneumothorax and pleural effusion were 93.79%/98.57% and 91.34%/98.30%, respectively.
“Our deep-learning algorithms are designed to rapidly and accurately detect abnormalities, thereby ensuring that critical cases are flagged for clinical review promptly,” says Julien Vidal, CEO of AZmed, in a release.
AZmed’s products are used in over 2,500 centers across 55 countries. With AZchest now FDA-cleared for US use, healthcare providers gain access to the solution. In line with AZmed’s evolving product portfolio, Rayvolve for chest pathologies has been rebranded as AZchest.
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