GE Healthcare gets FDA approval for AI critical care tool

For purposes of accessibility, the new suite is embedded on a mobile x-ray device, enabling hospitals to try AI without making investments into additional IT infrastructure.
Jeff Rowe

GE Healthcare has received FDA approval for new AI, Critical Care Suite 2.0, that helps bedside staff and radiologists assess patients before intubation with Endotracheal Tube (ETT) placements. The company says Critical Care Suite 2.0 consists of five AI solutions and is an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.

“The pandemic has proven what we already knew – that data, AI and connectivity are central to helping front line clinicians deliver intelligently efficient care,” said Jan Makela, President and CEO, Imaging at GE Healthcare, in a statement. “GE Healthcare is not only accelerating the development and access of new tools to help hospital staff keep up with demand, but also leading the way on COVID-era advancements that will transform the industry and have a long-lasting impact after the pandemic.”

The company says that anywhere from 5% to 15% of COVID-19 cases require intensive care surveillance and intubation for ventilatory support, and over the past year it has supplied 200 hospitals in the US with the ETT systems under emergency use protocols.  The new suite can help radiologists triage and prioritize cases, as well as automating processes that can help reduce review times for X-rays – which can take up to eight hours even if marked as urgent.

Using the AI, ETTs are automatically identified in chest X-ray images, providing feedback to the clinician on positioning within seconds and warning them if it hasn’t been place correctly. Improper positioning of the ETT during intubation can lead to various complications, including a pneumothorax, a type of collapsed lung. 

Research shows that up to a quarter of patients who are intubated outside of the operating room have misplaced ETTs on chest X-rays, which can lead to hyperinflation of the lungs, collapsed lung (pneumothorax), cardiac arrest and death.

With FDA approval, the tool can continue to be sold outside of the public health emergency.

“Seconds and minutes matter when dealing with a collapsed lung or assessing endotracheal tube positioning in a critically ill patient,” said Dr Amit Gupta, director of diagnostic radiography at University Hospital Cleveland Medical Centre in the US. “In several COVID-19 patient cases, the pneumothorax AI algorithm has proved prophetic – accurately identifying pneumothoraces/barotrauma in intubated COVID-19 patients, flagging them to radiologist and radiology residents, and enabling expedited patient treatment. Altogether, this technology is a game changer, helping us operate more efficiently as a practice, without compromising diagnostic precision."

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