GE Healthcare have announced that they have received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.
GE have distributed this solution under the FDA COVID-19 imaging guidance since November 2020, citing its potential to impact clinicians who were experiencing an influx of critically ill COVID-19 patients who required ventilation. Research shows that up to 25 percent of patients intubated outside of the operating room have misplaced ETTs on chest x-rays, which can lead to severe complications for patients, including hyperinflation, pneumothorax, cardiac arrest and death. Moreover, as COVID-19 cases climb, with more than 250 million confirmed worldwide, anywhere from 5-15 percent require intensive care surveillance and intubation for ventilatory support. Over the past year, 200 hospitals have deployed the technology to assist with ETT placements.
The FDA have now granted 510(k) clearance for this solution allowing its continued sale outside of the public health emergency.
