FDA Clears GE Healthcare's AI Algorithms Embedded on Mobile X-Ray Device

GE Healthcare announced the Food and Drug Administration's 510(k) clearance of Critical Care Suite, a collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built-in collaboration with UC San Francisco (UCSF), using GE Healthcare's Edison platform, the AI algorithms help to reduce the turn-around time it can take for radiologists to review a suspected pneumothorax, a type of collapsed lung. Additional partners in the development of Critical Care Suite include St. Luke's University Health Network, Humber River Hospital, and CARING – Mahajan Imaging – India. A prioritized "STAT" X-ray can sit waiting for up to eight hours for a radiologist's review1. However, when a patient is scanned on a device with Critical Care Suite, the system automatically analyzes the images by simultaneously searching for a pneumothorax.