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FDA Clears AI Software for Enhanced Lung Nodule Detection on Chest X-Rays

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Tailored for incidental findings on chest radiographs, the qXR for Lung Nodule (qXR-LN) software utilizes artificial intelligence (AI) to help detect suspected pulmonary nodules ranging between 6 to 30 mm.

The Food and Drug Administration (FDA) has granted 510(k) clearance for the artificial intelligence (AI)-enabled qXR for Lung Nodule (qXR-LN) software, which may enhance detection of pulmonary nodules on chest X-rays.

Qure.ai, the developer of the software, said qXR-LN detects and highlights regions of suspected pulmonary nodules, ranging between 6 to 30 mm in size. Geared to diagnosing incidental findings on chest radiographs, the AI software can also be utilized as a second reader in the review of AP and PA chest radiographs, according to Qure.ai.

The company noted that one multicenter study, involving 40 sites, revealed a 94 percent AUC for qXR-LN in stand-alone detection of lung nodule detection.

“Solutions like Qure.ai's qXR-LN are a significant step towards establishing new possibilities in pulmonary imaging, particularly within oncology. The need for early-stage lung cancer detection is crucial, and tools like qXR-LN can play a significant role in the early detection of incidental nodules,” noted Vishisht Mehta, M.D., F.C.C.P., the Director of Interventional Pulmonology at the Lung Center of Nevada in Las Vegas.

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