GE Healthcare Leads FDA AI-Enabled Medical Device Authorizations for Fourth Year
GE Healthcare has once again topped the U.S. Food and Drug Administration (FDA) list of authorized AI-enabled medical devices, marking the fourth consecutive year it holds this position. With 100 AI-related device authorizations to date in the U.S., the company’s commitment to integrating artificial intelligence into healthcare technologies is clear and ongoing.
This milestone highlights GE Healthcare’s sustained investment in research and development aimed at enhancing diagnostic confidence, improving healthcare professional efficiency, and supporting precision care across various medical fields. Their AI-driven solutions span smart devices, software, and cloud-based platforms, all designed to improve patient outcomes and streamline clinical workflows.
Driving Innovation with Responsible AI
GE Healthcare prioritizes responsible AI principles such as safety, transparency, validity, explainability, and fairness throughout product development. These principles guide the creation of AI-powered tools that address critical challenges in healthcare including staff shortages, burnout, rising costs, and workflow inefficiencies.
The FDA’s list of AI-enabled medical devices includes authorizations granted via 510(k) clearances, De Novo requests, or premarket approval (PMA). GE Healthcare’s 100 authorizations demonstrate a wide range of innovations across imaging modalities and care pathways such as oncology, cardiology, and neurology. These technologies help reduce care burden and improve operational efficiency within healthcare systems.
Examples of GE Healthcare’s AI Solutions
- AI-based Auto Positioning: Utilizes deep learning to automatically detect anatomical landmarks for patient positioning in CT and PET/CT devices like the Revolution Apex platform and Omni Legend. This reduces technologist effort to a single click and accelerates patient setup.
- AIR Recon DL: A deep learning algorithm for MRI image reconstruction that reduces artifacts and enhances clarity while cutting scan times by up to 50%. Since its 2020 launch, it has contributed to scanning over 50 million patients.
- LOGIQ Series Ultrasound: AI-powered automation and real-time workflow enhancements boost scanning speed and diagnostic precision. Intelligent anatomy recognition enables consistent, automated measurements, improving accuracy and confidence.
- Precision DL: Available on the Omni Legend PET/CT system, this deep learning image processing improves image quality with benefits similar to hardware-based Time-of-Flight reconstruction, enhancing contrast-to-noise ratio and quantitative accuracy without losing sensitivity.
- Venue Family Point-of-Care Ultrasound: Incorporates AI-powered Caption Guidance™ software that offers real-time instructions to help users, including those new to ultrasound, capture diagnostic-quality cardiac images.
Advancing Healthcare Solutions Beyond Imaging
GE Healthcare is moving beyond imaging to become a comprehensive healthcare solutions provider. The focus is on delivering integrated solutions that meet current clinical needs and anticipate future demands in a changing healthcare environment.
Collaboration with leading medical institutions, universities, and technology companies enables GE Healthcare to blend clinical expertise with advanced AI, cloud, and software technologies. This approach supports tackling major healthcare challenges such as aging populations, chronic disease management, and remote care.
For those in healthcare product development, understanding GE Healthcare’s approach to AI integration offers practical insight into how innovation and responsibility can align to improve care delivery and system efficiency.
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