GE HealthCare secures CE mark and FDA clearance for deep learning tech

GE HealthCare’s CleaRecon DL, a deep learning-based technology to enhance cone-beam computed tomography (CBCT) image quality, has received FDA 510(k) clearance and a European CE Mark. Now available with GE’s Allia image-guided surgery systems, CleaRecon DL reduces arterial blood flow artifacts and optimizes contrast distribution in liver, prostate, neurological, and endovascular procedures.

Clinical validation showed improved clarity in 98% of cases and a 94% boost in interpretation confidence. GE HealthCare says the technology supports more precise procedures and enhances workflow efficiency, marking a major step forward in CBCT imaging.

The company reported $2.14 billion in imaging revenue in Q1 2025, part of $4.8 billion in total revenue—a 3% year-over-year increase. However, GE expects a $500 million revenue hit in 2025 due to tariffs introduced under the Trump administration. While some tariffs on Chinese imports have been eased, the impact on medtech manufacturing and sourcing remains significant.

18-05-2025