FDA Clears Gleamer’s ChestView AI Software for CXR

The Food and Drug Administration (FDA) has granted 510(k) clearance for ChestView, an artificial intelligence (AI)-enabled software, which may enhance detection of a variety of abnormalities on chest X-rays (CXRs).

In a 2023 retrospective study involving 500 patients, researchers found that adjunctive use of the ChestView software led to an average increased detection of 26.2 percent for pneumothorax, 8.5 percent for pleural effusion and 14.1 percent for consolidation.

The authors of the study, published in Radiology, also noted an overall mean 31 percent reduction in CXR reading time with the use of ChestView. Specifically, researchers pointed out a 27 percent reduction in CXR reading time for thoracic radiologists and a 30 percent reduction for radiology residents.

"We believe ChestView will transform how chest X-rays are analyzed, making healthcare delivery faster, safer, and more effective for millions of patients,” noted Christian Allouche, the chief executive officer at Gleamer.