GE HealthCare Tops FDA List for AI Medical Devices, Surpassing 100 Authorizations in Drive Toward Precision Care
GE HealthCare has solidified its position as a global leader in AI-enabled medical technology by topping the U.S. Food and Drug Administration’s (FDA) list of AI-enabled medical device authorizations for the fourth consecutive year. With 100 FDA-listed authorizations as of 2025, the company continues to demonstrate its aggressive investment in innovation and its commitment to transforming healthcare delivery through artificial intelligence.
This significant milestone is not just a testament to GE HealthCare’s technological leadership but also a reflection of its sustained investment in research and development (R&D) aimed at advancing precision care. The company’s robust pipeline of AI-enhanced smart devices, software, and cloud-based platforms plays a pivotal role in improving healthcare outcomes, streamlining the work of clinical teams, and driving efficiency across the care continuum.
Commitment to Responsible and Scalable AI Innovation
“Our sustained leadership in AI-enabled medical devices reflects our commitment to research and development, which is powering the creation of next-generation solutions,” said Dr. Taha Kass-Hout, GE HealthCare’s Global Chief Science and Technology Officer. “These solutions are designed to address the toughest challenges our customers are facing, including care team shortages and burnout, rising costs, and inefficient workflows.”
Kass-Hout emphasized the importance of responsible AI integration, noting that GE HealthCare’s innovation strategy is underpinned by the company’s Responsible AI principles. These principles ensure that AI development at GE HealthCare prioritizes safety, transparency, fairness, explainability, and clinical validity. This framework supports not only technological progress but also ethical and effective integration into healthcare systems.
Strong Presence in FDA’s AI Device Listings
The FDA’s publicly available webpage, Artificial Intelligence-Enabled Medical Devices, provides transparency into device authorizations granted via 510(k) clearances, De Novo requests, or Premarket Approvals (PMA). With 100 device authorizations to date, GE HealthCare’s technologies span various imaging modalities and critical care pathways, including oncology, cardiology, and neurology.
These authorizations represent more than regulatory success—they reflect real-world impact and address customer demand, supporting GE HealthCare’s broader commercial growth. With a target of surpassing 200 FDA authorizations in the coming years, the company is poised to expand its market footprint even further.
AI-Powered Technologies Transforming Care
GE HealthCare’s portfolio of FDA-authorized AI-enabled technologies demonstrates the company’s ability to translate complex innovation into practical clinical tools. Among the standout solutions:
- AI-Based Auto Positioning: Leveraging deep learning, this technology automatically detects anatomical landmarks for precise patient orientation in CT and PET/CT scanners, such as the Revolution Apex and Omni Legend systems. It simplifies positioning to a single click, significantly speeding up the scanning process and reducing technologist workload.
- AIR™ Recon DL: A cutting-edge deep learning algorithm for MRI image reconstruction, AIR™ Recon DL enables clearer images with fewer artifacts and faster scan times—up to 50% quicker. Since its launch in 2020, over 50 million patients have benefited from this innovation, showcasing its wide-scale adoption and clinical value.
- LOGIQ™ Series Ultrasound Systems: This AI-powered suite of ultrasound tools enhances scanning speed, accuracy, and diagnostic confidence. With features like intelligent anatomy recognition, the LOGIQ Series provides automated, reproducible measurements for a range of clinical conditions—streamlining workflows and improving patient care.
- Precision DL: This AI-driven image processing technology is available on the Omni Legend PET/CT platform. It offers image quality enhancements typically associated with expensive hardware-based Time-of-Flight (ToF) solutions but without sacrificing sensitivity. Benefits include improved contrast-to-noise ratios, better quantitative accuracy, and enhanced lesion detectability.
- Venue Family Ultrasound with Caption Guidance™: Designed to democratize ultrasound usage, this AI software offers real-time, step-by-step guidance that enables even inexperienced operators to acquire diagnostic-quality cardiac images. This capability is especially valuable in emergency settings and remote care environments.
Advancing Healthcare from Devices to Systems
As GE HealthCare advances its transformation from an imaging company to a holistic healthcare solutions provider, these AI innovations represent only part of the broader vision. “We’re accelerating the pace of innovation to meet the urgency of today’s healthcare challenges,” Kass-Hout noted. “Reaching this milestone is also an important step along our journey of evolving from an imaging company to a healthcare solutions provider.”
The company’s evolving strategy focuses not only on individual devices but also on integrated, cloud-connected ecosystems that enable seamless workflows, cross-disciplinary collaboration, and smarter clinical decision-making. GE HealthCare is actively working with leading academic institutions, hospitals, and technology partners to accelerate the development and deployment of cutting-edge AI solutions.
Solving Global Healthcare Challenges Through Technology
Beyond FDA authorizations, GE HealthCare’s AI initiatives address urgent global healthcare challenges—such as aging populations, chronic disease management, remote and rural care access, and clinical staff shortages. Its R&D programs are deeply collaborative, often involving partnerships with top universities and medical institutions, ensuring that solutions are informed by real clinical needs.
The company’s responsible approach to AI, its ability to operationalize deep learning algorithms across diverse care settings, and its commitment to patient safety set it apart in a crowded medtech landscape. Whether it’s assisting novice clinicians with cardiac imaging or enabling radiologists to process more patients per day with fewer errors, GE HealthCare’s innovations are reshaping what’s possible in modern medicine.
