GE Healthcare, a subsidiary of American multinational conglomerate General Electric, has announced that it has been awarded the U.S. FDA (Food and Drug Administration) 510(k) approval for its AI (Artificial Intelligence) algorithm that will assist healthcare professionals to examine ETT (Endotracheal Tube) placements.
The AI solution is included in GE Healthcare’s Care Suite 2.0, the collection of the first AI algorithms entrenched on a mobile x-ray device for quality control, automated measurements, and case prioritization.
GE has dispersed this solution under the FDA COVID-19 guidelines since November 2020, stating its potential to affect clinicians who were undergoing an influx of ill COVID-19 patients who required ventilation.
According to research, 25% of patients intubated outside of the operating room have misdirected ETTs on chest x-rays, resulting in severe difficulties including hyperinflation, pneumothorax, cardiac arrest and death.
Furthermore, as COVID-19 cases surge, around 5-15% patients required intensive care and intubation for ventilatory support. Since last year, approximately 200 hospitals have implemented the technology to assist with ETT placements.
The FDA has now given the 510(k) clearance for this solution, allowing continuous sale outside of the public health emergency.
Jan Makela, President and CEO, Imaging at GE Healthcare, said that at GE Healthcare, they saw the budding role of Critical Care Suite 2.0 in helping hospitals managing the crisis caused by rise in number of patients who required ETT placements during the pandemic. Their firm worked rapidly with the FDA to ensure that the solution was available to clinicians.
He further said that they are ecstatic to receive FDA clearance for this important solution. The COVID-19 pandemic has verified that data, AI, and connectivity are important to help front line workers to deliver perceptively efficient care.
Their firm is fast-tracking the development and access of new tools to help hospital staff fulfil the demand and leading the way on COVID-era advancements, which will revolutionize the industry and have a long-lasting influence after the pandemic.