FDA Clears GE Healthcare's AI Triage Algorithm on X-Ray Device

The US Food and Drug Administration (FDA) has cleared an artificial intelligence (AI) algorithm from GE Healthcare that analyzes chest x-rays for pneumothorax and helps flag suspected cases for radiologists to prioritize reading, the company announced today. The algorithm, part of a set of other quality-assurance algorithms named the Critical Care Suite, was developed to run on a GE Healthcare mobile x-ray device. The software is not yet for sale, and an outside expert expressed concern about its false positive rate. The idea for the application came from bedside clinician experience of waiting for radiologists to read chest x-rays, said Rachael Callcut, MD, MSPH, a surgeon and director of data science for the Center for Digital Health Innovation at the University of California, San Francisco. UCSF proposed developing the feature as part of a development partnership with GE Healthcare.