AZmed’s AI Chest X-ray Software Nabs 2 FDA Clearances

AZmed, a Paris-based company specialized in artificial intelligence (AI) in medical imaging, earned two new U.S. Food and Drug Administration (FDA) clearances for its AZchest AI tool.

The FDA nods include applications to help radiologists interpret and detect chest X-rays for lung nodules and triage capabilities for pneumothorax and pleural effusion.

The company said a standalone study on chest X-rays demonstrated that AZchest has 88.47% sensitivity in detecting lung nodules, with specificity of 82.94%. In a controlled, multi-reader multi-case trial, experienced radiologists interpreted a standard set of chest X-rays with and without using AZchest—when it was used, sensitivity grew by 10% to reach 89.35%.

The algorithm also confirmed high detection performance for triaging of pneumothorax and pleural effusion: 93.79%/98.57% and 91.34%/98.3%, respectively.

AZmed believes the tool offers a quantifiable diagnostic advantage in real clinical practice and supports cancer detection at early stages. The new validated capability supports AZchest’s potential to reduce workload on radiologists, as well.

“We are proud to add two new FDA clearances to our portfolio,” said Julien Vidal, CEO of AZmed. “Our deep learning algorithms are designed to rapidly and accurately detect abnormalities, thereby ensuring that critical cases are flagged for clinical review promptly.”

The company also noted that in line with an evolving product line, Rayvolve for chest pathologies was rebranded as AZchest.