Critical Care Suite

GE Healthcare

**Currently only available with GE Healthcare systems.**
Critical Care Suite, powered by Edison, is a collection of AI algorithms for automated measurements, triage and quality control embedded on an X-ray system. The on-device artificial intelligence solution is designed to identify and help prioritize critical cases such as pneumothorax and identify endotracheal tube positioning.

In addition to the detection algorithms, the application also includes Quality Care Suite algorithms that operate in parallel and aids by automatically rotating images as well as analyzing and flagging protocol and field of view errors.

Information source: Vendor
Last updated: September 4, 2024

General Information

General
Product name	Critical Care Suite
Company	GE Healthcare
Subspeciality	Chest
Modality	X-ray
Disease targeted	Pneumothorax
Key-features	Endotracheal tube tip to carina measurement, detection and flagging of pneumothorax and insufficient image quality, flagging of quality checks on acquired image: Intelligent Protocol Check, Intelligent Auto Rotate, Intelligent Field of View
Suggested use	Before: adapting worklist order, flagging acute findings, image quality checks During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand)

Technical Specifications

Data characteristics
Population	Adult-size patients. Suspected of pneumothorax or intubated.
Input	Frontal Chest X-rays, PA/AP, 2D, acquired on mobile or fixed X-ray systems
Input format	DICOM
Output	On-device notifications, automated measurements, worklist prioritization, auto-rotated image, AI prediction score, image overlay
Output format	DICOM, secondary capture DICOM, public DICOM tags
Technology
Integration	Embedded on-device and only available on GE systems
Deployment	Locally on dedicated hardware: embedded in X-ray device (available as an add-on software on GE’s AMX 240 and AMX Navigate mobile X-ray system). The Pneumothorax detection and automated quality checks are also available on Definium Tempo, Definium 646 HD and Definium 656 HD fixed X-ray systems.
Trigger for analysis	Automatically, right after the image acquisition
Processing time	< 3 sec

Regulatory

Certification
CE	Certified, Class IIa , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital X-ray system for the presence of critical findings (pneumothorax), quality checks and/or measurements (endotracheal tube positioning). Critical Care Suite is indicated for adult-size patients. Indications for Use (full description): Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital X-ray system for the presence of critical findings, quality checks and/or measurements. When Critical Care Suite includes the Pneumothorax algorithm, it produces an onscreen notification, image overlay, and an image flag to enable case prioritization and diagnosis of critical findings (pneumothorax). This information is also transmitted to the radiologist for review. When Critical Care Suite includes the Endotracheal Tube algorithm, it produces an on screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review. Intended users include the clinical care team and radiologist. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray image by a qualified physician. Critical Care Suite is indicated for adult-size patients.

Market

Market presence
On market since	09-2019
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	One-off payment
Based on	Number of devices

Evidence

Evidence
Peer reviewed papers on performance	Evaluation of the impact of artificial intelligence-assisted image interpretation on the diagnostic performance of clinicians in identifying pneumothoraces on plain chest X-ray: a multi-case multi-reader study (read)
Non-peer reviewed papers on performance
Other relevant papers