GE Healthcare receives FDA clearance of first AI algorithms embedded on-device

Sept. 16, 2019
Helps radiologists prioritize critical cases with suspected collapsed lung by immediately flagging critical cases to radiologists for triage

GE Healthcare has announced the Food and Drug Administration’s 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s Edison platform, the AI algorithms help to reduce the turn-around time it can take for radiologists to review a suspected pneumothorax, a type of collapsed lung.

A prioritized “STAT” X-ray can sit waiting for up to eight hours for a radiologist’s review. However, when a patient is scanned on a device with Critical Care Suite, the system automatically analyzes the images by simultaneously searching for a pneumothorax.

“Currently, 62 percent 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,” adds Jie Xue, President & CEO, X-ray, GE Healthcare. “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.”

If a pneumothorax is suspected, an alert – along with the original chest X-ray – is sent directly to the radiologist for review via picture archiving and communication systems (PACS). The technologist also receives a subsequent on-device notification2 to give awareness of the prioritized cases.

“Clinicians are always looking for clinically proven methods to increase outcomes and improve the patient experience,” says Dr. Rachael Callcut, Associate Professor of Surgery at UCSF, a surgeon at UCSF Health and Director of Data Science for the Center for Digital Health Innovation, who partnered in the development of 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.”

Quality-focused AI algorithms simultaneously analyze and flag protocol and field of view errors as well as auto rotate the images on-device. Critical Care Suite and the quality algorithms were developed using GE Healthcare’s Edison platform – which helps deploy AI algorithms quickly and securely – and deployed on the company’s Optima XR240amx system.

Additionally, embedding Critical Care Suite on-device offers several benefits to radiologists and technologists. For critical findings, GE Healthcare’s algorithms are a fast and reliable way to ensure AI results are generated within seconds of image acquisition, without any dependency on connectivity or transfer speeds to produce the AI results. These results are then sent to the radiologist at the same time that the device sends the original diagnostic image, ensuring no additional processing delay. Also, automatically running quality checks on-device integrates them into the technologist’s standard workflow and enables technologist actions – such as rejections or reprocessing – to occur at the patient’s bedside and before the images are sent to PACS.

 “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,” says Kieran Murphy, President & CEO, GE Healthcare, in a press release. “By integrating AI into every aspect of care, we will ultimately improve patient outcomes, reduce waste and inefficiencies, and eliminate costly errors.”