FDA Clears GE Healthcare's Critical Care Suite Chest X-ray AI
June 14, 2023September 12, 2019 – GE Healthcare announced the U.S. Food and Drug Administration’s (FDA) 510(k)...
Chest X-ray showing collapsed lung, or pneumothorax. Image courtesy of Rachael Callcut, MD.
CDHI partnered with GE Healthcare to develop, validate, and gain regulatory clearance for artificial intelligence (AI) algorithms that improve clinical workflows and patient outcomes.
The partnership achieved a significant milestone in 2019 when the first generation of the "Critical Care Suite," an AI-embedded algorithm that works with portable X-rays to rapidly screen for collapsed lung, received FDA clearance.