Le LÚzard
Classified in: Health, Science and technology, Covid-19 virus
Subjects: Photo/Multimedia, Product/Service

GE Healthcare Receives FDA Clearance for First X-ray AI to Help Assess Endotracheal Tube Placement


GE Healthcare today announced it has received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare's Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.

GE has distributed this solution under the FDA COVID-19 imaging guidance since November 2020, citing its potential to impact clinicians who were experiencing an influx of critically ill COVID-19 patients who required ventilation. Research shows that up to 25 percent3,4,5,6,7 of patients intubated outside of the operating room have misplaced ETTs on chest x-rays, which can lead to severe complications for patients, including hyperinflation, pneumothorax, cardiac arrest and death. Moreover, as COVID-19 cases climb, with more than 250 million confirmed worldwide8, anywhere from 5-15 percent require intensive care surveillance and intubation for ventilatory support9. Over the past year, 200 hospitals have deployed the technology to assist with ETT placements. The FDA has now granted 510(k) clearance for this solution allowing its continued sale outside of the public health emergency.

"At GE Healthcare, we saw the potential role of Critical Care Suite 2.0 in helping hospitals manage the crisis caused by the number of patients who needed ETT placements during the pandemic, requiring accelerated innovation, and we quickly worked with the FDA to make the solution available to clinicians. We are pleased to now have the FDA's clearance for this important solution," said Jan Makela, President and CEO, Imaging at GE Healthcare. "The pandemic has proven what we already knew ? that data, AI and connectivity are central to helping front line clinicians deliver intelligently efficient care. 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."

Up to 45% of ICU patients, including severe COVID-19 cases, receive ETT intubation for ventilation10,11,12. While proper ETT placement can be difficult, Critical Care Suite 2.0 uses AI to automatically detect ETTs in chest x-ray images and provides an accurate and automated measurement of ETT positioning to clinicians within seconds of image acquisition, displaying the results on the monitor of the x-ray system. The AI generated measurements ? along with an image overlay ? are then made accessible in picture archiving and communication systems (PACS). The average error is less than 1.0mm when calculating the endotracheal tube tip-to-carina vertical distance13. With these measurements, clinicians can determine if the ETT is placed correctly or if additional attention is required for proper placement.

Improper positioning of the ETT during intubation can lead to various complications, including a pneumothorax, a type of collapsed lung. While the chest x-ray images of a suspected pneumothorax patient are often marked "STAT," they can sit waiting for up to eight hours for a radiologist's review14. However, when a patient is scanned on a device with Critical Care Suite 2.0,15 the system automatically analyzes images and sends an alert for cases with a suspected pneumothorax ? along with the original chest x-ray ? to the radiologist for review in PACS. The technologist also receives a subsequent on-device notification16 to provide awareness of the prioritized cases.

"Seconds and minutes matter when dealing with a collapsed lung or assessing endotracheal tube positioning in a critically ill patient," explains Dr. Amit Gupta, Modality Director of Diagnostic Radiography at University Hospital Cleveland Medical Center and Assistant Professor of Radiology at Case Western Reserve University, Cleveland. "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."

To make the AI suite more accessible, Critical Care Suite 2.0 is embedded on a mobile x-ray device ? offering hospitals an opportunity to try AI without making investments into additional IT infrastructure, security assessments or cybersecurity precautions for routing images offsite.

Furthermore, the on-device AI offers several benefits to radiologists and technologists:

GE Healthcare worked with multiple academic research partners including UC San Francisco and the University Hospitals Cleveland Medical Center to develop the Critical Care Suite using GE Healthcare's Edison platform, which helps deploy AI algorithms quickly and securely. Critical Care Suite 2.0 is available on the company's AMX 240 and AMX Navigate mobile x-ray systems.

For more information on GE Healthcare and Critical Care Suite 2.0 visit the company's virtual RSNA booth or gehealthcare.com. Clinicians can also test the Critical Care Suite 2.0 algorithms by uploading their own anonymized chest x-ray images to gexray.ai.

About GE Healthcare:

GE Healthcare is the $18 billion healthcare business of GE (NYSE: GE). As a leading global medical technology, pharmaceutical diagnostics and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 47,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world.

Follow us on Facebook, LinkedIn, Twitter, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.


1 Rachh, Pratik et al. "Reducing STAT Portable Chest Radiograph Turnaround Times: A Pilot Study." Current Problems in Diagnostic Radiology Vol. 47, No. 3 (n.d.): 156?60. https://www.sciencedirect.com/science/article/abs/pii/S0363018817300312?via=ihub.

2 FDA 510(k) K211161 and CE-mark.

3 Jemmett ME, Kendal KM, Fourre MW, Burton JH. Unrecognized misplacement of endotracheal tubes in a mixed urban to rural emergency medical services setting. Acad Emerg Med 2003;10:961?5.

4 Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med 2001;37:32?7.

5 Lotano R, Gerber D, Aseron C, Santarelli R, Pratter M. Utility of postintubation chest radiographs in the intensive care unit. Crit Care 2000;4:50?3.

6 McGillicuddy DC, Babineau MR, Fisher J, Ban K, Sanchez LD.

7 Is a postintubation chest radiograph necessary in the emergency department? Int J Emerg Med 2009;2:247?9.

8 WHO Coronavirus Disease (COVID-19) Dashboard. Retrieved November 8, 2020, from https://covid19.who.int/.

9 M÷hlenkamp S, Thiele H. "Ventilation of COVID-19 patients in intensive care units." Nature Public Health Emergency Collection. 2020 Apr 20 :1?3

10 Hannah Wunsch, Jason Wagner, Maximilian Herlim, David Chong, Andrew Kramer, and Scott D. Halpern. ICU Occupancy and mechanical ventilator use in the United States. Crit Care Med. 2013 Dec; 41(12): 10.1097/CCM.0b013e318298a139.

11 Dawei Wang, Bo Hu, Chang Hu, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus?Infected Pneumonia in Wuhan, China. JAMA. 2020;323(11):1061-1069. doi:10.1001/jama.2020.1585

12 Lingzhong Meng, M.D.; Haibo Qiu, M.D.; Li Wan, M.D.; Yuhang Ai, M.D.; Zhanggang Xue, M.D.; et al. Intubation and Ventilation amid the COVID-19 Outbreak: Wuhan's Experience. Anesthesiology 6 2020, Vol.132, 1317-1332.

13 GE Healthcare data on file.

14 Rachh, Pratik et al. "Reducing STAT Portable Chest Radiograph Turnaround Times: A Pilot Study." Current Problems in Diagnostic Radiology Vol. 47, No. 3 (n.d.): 156?60. https://www.sciencedirect.com/science/article/abs/pii/S0363018817300312?via=ihub.

15 The Pneumothorax AI algorithm is also available with GE Healthcare's Critical Care Suite 1.0 on the Definium Tempo, Definium 646 HD and Definium 656 HD digital radiography systems.

16 The technologist on-device notification is generated after a delay, post exam closure, and it does not provide any diagnostic information, nor is it intended to inform any clinical decision, prioritization, or action.


These press releases may also interest you

at 12:40
The "Fertility Treatments Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering. The global fertility treatments market is expected to grow from $14.27 billion in 2020 to $15.74...

at 12:35
Bone Solutions Inc. (BSI), an orthobiologics technology company located in Colleyville, Texas, announced today the immediate commercial launch of Mg OSTEOINJECT, the first injectable bone void filler in the U.S. to incorporate magnesium - a critical...

at 12:35
The "Protein Expression Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering. The global protein expression market is expected to grow from $2.01 billion in 2020 to $2.13 billion...

at 12:33
Board Safely LLC today announced the launch of a virtual, nurse-supervised COVID test certification platform allowing Americans to receive reliable, fully-supervised antigen test results quickly and conveniently, for travel and gatherings. The...

at 12:20
The "Autoinjectors- Market Insights, Competitive Landscape and Market Forecast-2026" report has been added to ResearchAndMarkets.com's offering. Global Autoinjectors Market was valued at USD 1.80 billion in 2020, growing at a CAGR of 20.50% during...

at 12:14
First 5 LA, an independent public agency that supports the safe and healthy development of young children and their families in Los Angeles County, and ForáThe Village, a nonprofit community organization that provides free doula services and...



News published on 15 november 2021 at 15:05 and distributed by: