GE HealthCare Leads in AI-Enabled Device Authorizations for Fourth Straight Year

GE HealthCare has once again topped the U.S. FDA’s list of AI-enabled medical device authorizations, reaching a milestone of 100 cleared solutions as of July 2025. This marks the fourth consecutive year the company has led the industry in this category, highlighting its growing influence in AI-powered medical technologies.

The milestone reflects GE HealthCare’s continued investment in integrating AI into imaging systems, software, and cloud-based platforms—key pillars in its strategy to improve diagnostic accuracy, clinical workflows, and productivity for care teams. The company is targeting over 200 FDA authorizations by 2028.

“Our leadership in AI innovation is driven by a strong R&D pipeline focused on solving real-world healthcare challenges—from workforce shortages to inefficient workflows,” said Dr. Taha Kass-Hout, Global Chief Science and Technology Officer at GE HealthCare. “We embed Responsible AI principles at every step, prioritizing safety, transparency, and fairness.”

GE HealthCare’s AI-enabled tools support clinical decision-making across oncology, cardiology, and neurology. Highlights include:

• AI Auto Positioning in CT and PET/CT devices (e.g., Revolution Apex, Omni Legend) streamlines patient alignment using deep learning for faster, more consistent imaging setup.
• AIR™ Recon DL enhances MRI image quality and reduces scan time by up to 50% using deep learning-based reconstruction—over 50 million scans have been performed with the technology since 2020.
• LOGIQ™ Series Ultrasound Systems integrate AI for automated measurements, real-time optimization, and improved diagnostic precision in a broad range of clinical use cases.
• Precision DL on the Omni Legend PET/CT system boosts image quality and diagnostic value without hardware-based ToF, improving contrast and quantitative accuracy.
• Venue Family Ultrasound systems use Caption Guidance™ AI to provide real-time instruction, enabling even novice users to capture diagnostic-quality cardiac images.

As the company evolves from a traditional imaging provider to a holistic healthcare solutions partner, it continues to collaborate with academic, clinical, and technology leaders to bring forward-thinking, scalable innovations to market.

GE HealthCare’s AI momentum reflects a broader mission: to meet the urgency of today’s care challenges while shaping the future of digital healthcare in a responsible, clinically meaningful way.