GE HealthCare has gained 501(k) clearance from the US Food and Drug Administration (FDA) for its CleaRecon DL technology, as well as a European CE Mark.
An AI-based technology for improving the quality of cone-beam computed tomography (CBCT) images, CleaRecon DL is available for use with GE HealthCare’s Allia range of image-guided surgery systems.
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Using a deep learning algorithm based on population data and tests undertaken by clinicians, the software removes streak artifacts caused by arterial blood flow. It also adjusts the distribution of contrast during CBCT acquisitions in liver, prostate, neurological, and endovascular aortic repair procedures.
According to GE HealthCare’s clinical validation of the technology, CBCT images reconstructed with CleaRecon DL proved to be clearer than conventional CBCT images in 98% of cases. In addition, the technology has been shown to improve CBCT image interpretation confidence by 94%.
Arnaud Marie, general manager of interventional solutions at GE HealthCare, said the introduction of CleaRecon DL represents a “leap forward” in the advancement of CBCT.
He comments: “By improving image quality and reducing artifacts, this technology can empower clinicians to perform procedures with greater precision and confidence.
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By GlobalData“This solution builds on our portfolio of tools aimed at improving the user experience and workflow efficiency, enabling clinicians to deliver more accurate and effective interventions for enhanced patient outcomes.”
According to GlobalData analysis, the global diagnostic imaging space is forecast to reach a valuation of almost $55bn by 2033, up from $36.3bn in 2023.
GE HealthCare reported imaging revenues of $2.14bn in its Q1 2025 financials. While the $4.8bn total for revenues during the quarter represented a year-over-year increase of 3%, the imaging giant also revealed that it expects overall revenues for 2025 to take a hit of around $500m due to the Trump administration’s imposition of tariffs.
While the White House has since reduced the 145% tariffs imposed on Chinese imports, which affect many medtech companies due to a reliance on goods manufactured and sourced from the country, other major players in the space have also factored anticipated headwinds from Trump’s tariffs into their 2025 financial outlook.
