FDA Clears GE Healthcare's X-ray AI Suite

Samara Rosenfeld
SEPTEMBER 12, 2019
chest X-ray

The U.S. Food and Drug Administration granted 510(k) clearance to GE Healthcare’s Critical Care Suite — a collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device, the healthcare business division of GE announced today.
 
Using GE Healthcare’s Edison platform, the AI aims to help reduce the turnaround time it takes radiologists to review suspected pneumothorax, a type of collapsed lung.
 
“By integrating AI into every aspect of care, we will ultimately improve patient outcomes, reduce waste and inefficiencies and eliminate costly errors,” said Kieran Murphy, president and CEO of GE Healthcare.
 
If a patient is scanned on a device with Critical Care Suite, it will automatically analyze the images by searching for a pneumothorax, GE Healthcare claims. If suspected, an alert with the original X-ray is sent straight to the radiologist to review.
 
The AI analyzes and flags protocol and field of view errors and automatically rotates the images on the device.
 
The suite automatically runs quality checks on the device, which integrates them into the technologist’s workflow and could allow for rejections or reprocessing, GE Healthcare said.
 
“Clinicians are always looking for clinically proven methods to increase outcomes and improve the patient experience,” said Rachael Callcut, M.D., a surgeon at UCSF Health, which helped develop the Critical Care Suite. “When a patient X-ray is taken, the minutes and hours it takes to process and interpret the image can impact the outcome in either direction. AI gives us an opportunity to speed up diagnosis and change the way we care for patients, which could ultimately save lives and improve outcomes.”
 
Prior studies have found AI as a promising tool for chest X-rays.
 
AI can reduce the time needed to process abnormal chest X-rays and can help identify patients at an increased risk of long-term mortality based on their chest X-rays, according to some of those studies.
 
Other companies are focused on this area of study as well.
 
In April, Enlitic, a developer of machine-learning platforms to improve diagnoses, announced a $15 million funding round for its AI solution that interprets chest X-rays and triages normal from abnormal scans. 

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