With 72 510(k) clearances or authorizations, GE HealthCare has topped the FDA's list of AI-enabled medical devices for a third consecutive year.

GE HealthCare's business strategy emphasizes the integration of AI and machine learning into advanced technologies such as medical imaging and molecular diagnostics to tailor diagnosis, treatment, and ongoing patient management for optimal outcomes. By focusing on precision care, the company aims to address challenges like data overload, physician burnout, and real-time operational efficiency.

“GE HealthCare is committed to pushing the boundaries of what is possible, utilizing advanced technologies like AI, to help deliver the future of healthcare. We are leveraging our deep industry expertise, and the unique capabilities honed through offering leading medical devices for more than 125 years to create solutions that solve our customers’ biggest challenges. GE HealthCare’s continued leadership in AI-based medical device authorizations shows our dedication to deliver groundbreaking technology that transforms healthcare and enhances patient outcomes,” said Dr. Taha Kass-Hout, the company's chief Science and Technology officer.
Among the 72 GE HealthCare authorizations are devices from its recent acquisitions of BK Medical, Caption Health, and MIM Software.

The next three companies closest behind GE HealthCare with AI device clearances were Siemens Healthineers (64), Canon (28), and Philips (27).

The FDA’s Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices webpage lists devices granted through 510(k) clearances, De Novo requests, or premarket approval (PMA). In total, the list contains over 850 devices.

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