GE HealthCare has submitted a 510(k) premarket application to the US Food and Drug Administration (FDA) for its deep learning technology, CleaRecon DL.
CleaRecon DL is designed to improve the quality of cone-beam computed tomography (CBCT) images by leveraging AI-based 3D reconstruction in the interventional suite.
It employs advanced AI-based reconstruction to remove streaks from images while preventing the need for introducing additional artefacts, to improve image clarity.
Also, the technology optimises CBCT analysis, providing clinicians with clear images and supporting wider adoption of CBCT in routine clinical practice, said GE HealthCare.
GE HealthCare global intervention general manager Arnaud Marie said: “GE HealthCare has been a leader in CBCT for more than two decades, offering continued innovation through offerings such as augmented guidance solutions designed to improve procedure outcomes, as well as developing a wide-bore platform capable of acquiring CBCT with obese patients, even with their arms down.
“Over the years, artefacts created in scans through the natural movement of the body and the distribution of contrast have posed another significant challenge to clinicians when obtaining CBCT images – posing a major barrier to adoption of CBCT technology.
“We designed CleaRecon DL to address this challenge so physicians and their patients can benefit from this advanced imaging technology.”
According to GE HealthCare, demand for minimally invasive procedures is growing and is committed to helping clinicians use image guidance technologies to their full potential.
The company plans to offer the new CleaRecon DL technology on its Allia Image-Guided Solutions (IGS) Systems.
In addition to CleaRecon DL, GE HealthCare is also introducing OnWatch Predict, a predictive monitoring solution intended for interventional image-guided systems.
OnWatch Predict is designed to provide enhanced service and increase system availability for on-time diagnosis, invasive procedures, and treatments.
It combines real-time system diagnostics with user interface monitoring, image chain health analysis, and X-ray generation tracking, to anticipate potential component failures.
Recently, GE HealthCare launched Sonic DL for 3D, a new addition to its imaging portfolio, to advance magnetic resonance imaging (MRI) scans for several clinical applications.
