GE HealthCare Seeks FDA Approval for CleaRecon DL

GE HealthCare (Nasdaq:GEHC) revealed its recent submission of the CleaRecon DL for FDA 510(k) approval. This cutting-edge deep learning tool, developed in Chicago, enhances cone-beam CT (CBCT) image quality with AI-driven 3D reconstruction capabilities, specifically designed for use in interventional settings.

CleaRecon DL aims to be integrated within GE HealthCare’s Allia image-guided solutions, capitalizing on AI techniques to refine images by eliminating streaks without introducing additional distortion. This innovation promises to bolster CBCT image clarity and analysis.

According to GE HealthCare, this technology aligns with their mission to drive daily usage of CBCT in medical practices.

“GE HealthCare has pioneered CBCT technology for over 20 years, consistently innovating with augmented guidance solutions that enhance clinical outcomes and crafting a wide-bore system that accommodates even obese patients with arms at their sides,” stated Arnaud Marie, Global Intervention GM at GE HealthCare. “Artifacts from body movements and contrast distribution have long been hurdles in accurate CBCT imaging, therefore hindering CBCT adoption. CleaRecon DL is our solution to these obstacles, encouraging clinicians to leverage this sophisticated imaging technology for their patients’ benefit.”

Furthermore, GE HealthCare aims to present OnWatch Predict—an advanced predictive monitoring system for interventional image-guided equipment—ensuring timely diagnostics and procedures through improved service and system reliability.