GE Healthcare’s Endotracheal X-Ray AI Cleared

GE Healthcare has received 510(k) clearance from the FDA for an artificial intelligence (AI)-based algorithm to help clinicians assess endotracheal tube placements.

The software is one of five algorithms included in the company’s Critical Care Suite 2.0, which can be embedded in a mobile x-ray device for automated measurements, case prioritization and quality control.

GE has been offering the algorithm since November 2020 based on the FDA’s COVID-19 emergency guidance for imaging, citing its potential to help clinicians treating critically ill COVID-19 patients who require ventilation.