GE HealthCare has submitted a 510(k) application to the US Food and Drug Administration (FDA) for CleaRecon DL, a deep learning technology that uses AI-based 3D reconstruction to improve the quality of cone-beam computed tomography (CBCT) images.
The company provided an update about the FDA submission at the Radiological Society of North America’s (RSNA) 2024 meeting, currently taking place in Chicago, US, from 1 to 4 December.
The technology will be available for the company’s range of Allia image-guided solutions (IGS) systems, improving image quality by removing streaks to heighten clinicians’ confidence in image interpretation in their analysis of CBCT data.
The Allia range includes Allia IGS Pulse, which is aimed at enhancing workflow to diagnose and treat cardiovascular diseases in interventional cardiology, the system received FDA clearance in October 2023.
Arnaud Marie, general manager for global intervention at GE HealthCare, commented: “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 GlobalData’s Market Size & Growth database, the global diagnostic imaging space was valued at around $36.3bn in 2023 and is forecast to reach a valuation of around $54.8bn by 2033.
In other RSNA news, Philips showcased its next-generation BlueSeal 1.5T magnetic resonance imaging system at the meeting, and US-based radiology practice Radiology Partners (RP) announced a partnership with RADPAIR to further the development of generative AI use in radiology.
GE HealthCare also launched Sonic DL, another deep learning technology that is designed to expedite magnetic resonance imaging (MRI) scans across various clinical applications.
This week, the medtech giant entered an agreement to purchase the remaining 50% stake in Nihon Medi-Physics (NMP) from Sumitomo Chemical, having held 50% in NMP since acquiring Amersham in 2004.
