GE HealthCare Tops FDA’s List of AI Authorizations for 4th Year, Driving Growth with AI-Enabled Medical Devices

GE HealthCare has once again solidified its leadership in the rapidly evolving field of AI-enabled medical devices, announcing today that it has topped the U.S. Food and Drug Administration’s (FDA) list of AI authorizations for the fourth year in a row. With a landmark 100 authorizations to date, this achievement underscores GE HealthCare’s strategic investment in research and development (R&D) and its commitment to integrating artificial intelligence across its diverse portfolio of medical devices.

This consistent performance highlights GE HealthCare’s pivotal role in driving the growth of AI within the healthcare industry. The company’s AI-enabled devices are designed to enhance precision care, improve diagnostic accuracy, streamline workflows, and ultimately, improve patient outcomes. These solutions are proving to be in high demand, directly contributing to GE HealthCare’s strong order book, revenue, and overall growth.

Among the notable innovations that have received FDA authorization are AI-based Auto Positioning for CT and PET/CT devices, which uses deep learning to automatically detect anatomical landmarks for precise patient orientation. Another significant advancement is AIR™ Recon DL, a pioneering deep learning algorithm for MRI image reconstruction that delivers sharper images faster, reducing scan times by up to 50% while enhancing clarity. The LOGIQ Series ultrasound systems also leverage AI for automated, real-time workflow enhancements and exceptional image quality, facilitating faster and more efficient scanning.

Dr. Taha Kass-Hout, GE HealthCare’s Global Chief Science and Technology Officer, emphasized the company’s dedication to responsible AI development. “Our sustained leadership in AI-enabled medical devices reflects our commitment to research and development, which is powering the creation of next-generation solutions,” he stated. Dr. Kass-Hout also highlighted the company’s focus on safety, validity, transparency, explainability, and fairness in every stage of product development.

GE HealthCare’s authorized devices span critical care pathways including oncology, cardiology, and neurology, addressing pressing challenges faced by healthcare systems such as care team shortages, rising costs, and inefficient workflows. The company has set an ambitious goal of securing over 200 FDA AI-enabled medical device authorizations by 2028, further solidifying its transition from an imaging company to a complete healthcare solutions provider. This ongoing innovation and regulatory success position GE HealthCare at the forefront of the transformative impact of AI on modern medicine.