GE Healthcare has secured the Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm that helps in assessing Endotracheal Tube (ETT) placements.

The AI solution is part of GE Healthcare’s Critical Care Suite 2.0, which is a collection of AI algorithms embedded on a mobile x-ray device for automated measurements.

Since November last year, the company has distributed the AI solution under the FDA Covid-19 imaging guidance to assist ETT placements.

According to GE Healthcare, the technology has been deployed by 200 hospitals over the past one year.

With the FDA clearance, the AI algorithm will now be available for continued sale outside of the public health emergency.

GE Healthcare imaging president and CEO Jan Makela said: “At GE Healthcare, we saw the potential role of Critical Care Suite 2.0 in helping hospitals manage the crisis caused by the number of patients who needed ETT placements during the pandemic, requiring accelerated innovation, and we quickly worked with the FDA to make the solution available to clinicians. We are pleased to now have the FDA’s clearance for this important solution.”

Using AI, Critical Care Suite 2.0 automatically detect ETTs in chest x-ray images. Within seconds of image acquisition, it offers an accurate and automated measurement of ETT positioning to clinicians, displaying the results on the monitor of the x-ray system.

During intubation, the ETT needs to properly positioned, as improper placement can lead to various complications, including a pneumothorax, a type of collapsed lung, the company said.

GE Healthcare has embedded Critical Care Suite 2.0 on a mobile x-ray device to expand the accessibility of the AI suite.

The benefits offered by the on-device AI include ETT positioning and critical findings; and elimination of processing delays.

To develop the Critical Care Suite, the company has worked with multiple academic research partners including UC San Francisco and the University Hospitals Cleveland Medical Center.

The suite was developed using GE Healthcare’s Edison platform, which is said to help in deploying AI algorithms quickly and securely.