The FDA Has Given The go Light to GE Healthcare’s Artificial Intelligence Algorithm for Patient Intubation

The new technique, which is based to GE’s Critical Care Suite 2.0, assists bedside personnel and radiologists in assessing patients ahead to intubation – such as prior to ventilation in patients with serious COVID-19 – and ensuring that their ETTs are correctly positioned.

Critical Care Suite, an industry-first suite of artificial intelligence (AI) algorithms incorporated into a mobile X-ray device, has received 510(k) clearance from the Food and Drug Administration. The AI algorithms were developed in partnership with UC San Francisco (UCSF) and GE Healthcare’s Edison platform to assist shorten the time it takes radiologists to assess a potential pneumothorax, a form of collapsed lung.

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The algorithm is utilized on a mobile X-ray device, according to GE, and is the first to be approved by the FDA for this purpose.

It can assist radiologists in triaging and prioritizing cases, along with automated operations to help cut X-ray review times, which can take up to eight hours even when categorized as urgent.

As per GE, anywhere between 5% to 15% of COVID-19 instances necessitate critical care observation and intubation for respiratory support, and it has provided the ETT devices to about 200 hospitals in the US under emergency use protocols over the last year.

Now that the FDA has approved it, it can be marketed outside the public health emergency.

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ETTs are automatically detected in chest X-ray pictures using Artificial Intelligence, providing instant feedback on location and informing the doctor if it hasn’t been placed appropriately.

It can also detect issues such as pneumothorax rapidly and send alerts to a physician including the X-ray imaging for review.

“The epidemic has confirmed everything we already knew:  AI, data, and connectivity are critical in assisting front-line physicians in providing intellectually effective care,” said Jan Makela, president and CEO of GE Healthcare’s Imaging division.

On chest X-rays, up to a quarter of intubated patients outside the operating room have misplaced ETTs, which can cause inflation of lungs, cardiac arrest, collapsed lung (pneumothorax), and death.

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“While working with a collapsed lung or analyzing endotracheal tube location in a critical patients, moments and seconds count,” said Dr Amit Gupta, director of diagnostic radiography at University Hospital Cleveland Medical Centre in the United States.

According to him, the algorithm already has proven its effectiveness in COVID-19 instances, detecting instances of pneumothorax and barotrauma — tissue harm induced by a stress changing body compartment volume of gas.

GE recently stated that it would split into three firms, with the healthcare division set to be sold off in 2023.