GE HealthCare Receives CE Marks for Two Cardiac Imaging and Assessment Systems

GE HealthCare has received CE marks for its Vscan Air SL wireless handheld ultrasound system with Caption AI, an artificial intelligence (AI)-driven software for rapid cardiac assessments at the point of care, and the ECG-less Cardiac computed tomography (CT) scanning on its Revolution Apex platform, which allows clinicians access to cardiac images without the aid of the patient’s electrocardiogram (ECG) signal/trace. 
 
“With diseases of the heart and blood vessels representing nearly one-third of all global deaths, innovation within cardiac diagnostics and treatment is one of our top priorities as a healthcare company,” said Phil Rackliffe, president and CEO of Ultrasound and Image Guided Therapies, GE HealthCare. “The integration of Caption AI on Vscan Air SL is a major step toward helping more users confidently capture diagnostic-quality images to inform clinical decisions when time is of the essence. With the recent CE mark, we’re eager to bring this technology to more healthcare providers around the world.”
 
The Vscan Air SL with Caption AI is ultraportable and is designed to help more healthcare professionals capture cardiac images and will be able to make better-informed diagnoses and treatment plans. Access to this novel technology enables earlier heart disease detection and expands cardiac care into primary care and emergency settings. 
 
Vscan Air SL with Caption AI can provide real-time, step-by-step visual guidance to optimize probe movements and includes a quality meter to ensure the user obtains the best possible images. Once a user captures an image, the AutoEF (ejection fraction) feature automatically calculates a left ventricular ejection fraction (LVEF), an important measure of heart function.
 
ECG-less Cardiac CT solution is already FDA-cleared and can acquire cardiac images without the aid of the patients’ ECG signal/trace. This technology is applied in examinations where it is clinically advantageous to prioritize patient access or speed when the ECG signal is unavailable. 
 
ECG-less Cardiac CT scanning further enhances the capabilities of the company’s Revolution Apex Elite, which already boasts a 160mm detector configuration and the ability to achieve one-beat, high-definition, motion-free coronary images at any heart rate. This system is available as a part of GE HealthCare’s broader Revolution Apex platform.
 
“Providing rapid, flexible and at the point of care cardiac diagnostics is critical in terms of patient outcomes – however, timely care can be extremely difficult to deliver, particularly within already-stretched healthcare systems where clinicians face time and resource constraints,” said Eigil Samset, general manager, Cardiology Solutions, GE HealthCare. “Through our innovative cardiology solutions and by leveraging the power of AI, we aim to address these challenges and help clinicians understand the complete story of their patients’ hearts as quickly as possible. I am thrilled that this suite of integrated cardiac care solutions is now accessible to more providers so that they are able to deliver efficient and timely patient care when and where it is needed most.”
 
Both technologies will be showcased at the European Society of Cardiology (ESC) Congress, in London, August 30-September 2, 2024.