AI Software for Fracture Detection Gets FDA Clearance

An emerging artificial intelligence (AI) software that reportedly reduces false negative rates for fractures by 29 percent has received FDA clearance. BoneView AI (Gleamer) detects fractures on X-rays, highlights regions of interest and submits them to radiologists for confirmation, according to the French company Gleamer. The company said the algorithm was designed to aid a variety of physicians who read X-rays in clinical practice. Noting that traumatic injuries account for one-third of visits to emergency rooms (ERs), Gleamer noted that errors with fracture interpretation, which are common during evening hours, can represent up to 24 percent of harmful diagnostic errors in the ER. The company said these errors may result from fatigue and non-expert reading of X-rays.