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Home » FDA clears GE Healthcare X-ray algorithms

FDA clears GE Healthcare X-ray algorithms

September 12, 2019 By Danielle Kirsh

GE-Healthcare-logoGE Healthcare said today that it has received FDA 510(k) clearance for its AI algorithms embedded in a mobile X-ray device.

The mobile X-ray device was built in collaboration with the University of California San Francisco using GE Healthcare’s Edison platform. The AI algorithms, which the company calls Critical Care Suite, are designed to reduce the turnaround time for radiologists to review chest X-rays for suspected pneumothorax, a condition that can lead to a collapsed lung.

“X-ray – the world’s oldest form of medical imaging – just got a whole lot smarter, and soon, the rest of our offerings will, too,” company president  & CEO Kieran Murphy said in a news release. “GE Healthcare is leading the way in the creation of AI applications for diagnostic imaging and taking what was once a promise and turning it into a reality. By integrating AI into every aspect of care, we will ultimately improve patient outcomes, reduce waste and inefficiencies and eliminate costly errors. Critical Care Suite is just the beginning.”

The Critical Care Suite system can automatically analyze patient images by searching for a pneumothorax — the presence of air in the cavity between the lungs and the chest wall, according to the company. Upon detecting the condition, the system will alert a radiologist and send the original chest X-ray images so the radiologist can review through picture archiving and communication systems. The technologist also receives a notification on the device.

“Currently, 62% of exams are marked ‘STAT’ or for urgent reading, but they aren’t all critical. This creates a delay in turnaround for truly critical patients, which can be a serious issue,” said Jie Xue, president & CEO of X-ray at GE Healthcare. “Not only does Critical Care Suite flag images with a suspected pneumothorax with impressive accuracy and enable radiologists to prioritize those cases immediately, but it also makes AI accessible. Our embedded AI algorithms offer hospitals an opportunity to try AI without making investments into additional IT infrastructure, security assessments or cybersecurity precautions for routing images offsite.”

GE Healthcare’s Critical Care Suite is deployed on the Optima Xr240amx system.

“Clinicians are always looking for clinically proven methods to increase outcomes and improve the patient experience,” said Dr. Rachael Callcut, associate professor of surgery at UCSF and a development partner for 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.”

Filed Under: 510(k), Food & Drug Administration (FDA), Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: GE Healthcare, University of California San Francisco

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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