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News|Articles|February 5, 2024

Adjunctive AI Powered Tool for Tuberculosis Detection Gets FDA's Breakthrough Device Designation

Author(s)Jeff Hall

With reported increases in tuberculosis cases after the COVID-19 pandemic, the qSpot-TB adjunctive artificial intelligence (AI) device may facilitate improved diagnosis of the disease on chest X-rays.

The Food and Drug Administration (FDA) has granted breakthrough device designation to qSpot-TB, an artificial intelligence (AI)-powered device, which may enhance tuberlosis (TB) detection on chest X-rays.

Qure.ai, the developer of qSpot-TB, said the device localizes signs of TB on chest X-rays and provides a conclusion of whether TB is present or not.

The emergence of the qSpot-TB device is particularly timely, according to the company, given statistics from the Centers for Disease Control and Prevention (CDC) showing 8,300 reported TB cases in 2022.

"The increase in TB cases in USA is a reminder about the importance of collective global efforts to continue the fight against the disease until eliminated. We cannot let our guard down. Innovative technology is a crucial component for accelerated progress to successfully end TB globally,” said Professor Kenneth G. Castro, M.D., a co-director of the Emory Tuberculosis Center, and professor of global health, epidemiology, and infectious disease with the Rollins School of Public Health at Emory University.


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