GE HealthCare announced it has topped the U.S. Food and Drug Administration (FDA) list of artificial intelligence (AI)-enabled medical devices for the third year running.
 
The Chicago-based medtech giant has received 72 listed 510(k) clearances or authorizations to date in the U.S. GE HealthCare also led the list when the FDA updated it in 2022 and 2023.
 
The company says investing in AI and machine learning is central to its strategy of enabling precision care. Precision care is a holistic approach that combines advanced medical imaging, AI, and molecular diagnostics to tailor diagnosis, treatment, and ongoing monitoring for the best outcomes.
 
GE HealthCare aims to tackle data overload, physician burnout, and real-time operational efficiency with AI-powered, purpose-built solutions.
 
“GE HealthCare is committed to pushing the boundaries of what is possible, utilizing advanced technologies like AI, to help deliver the future of healthcare,” said Dr. Taha Kass-Hout, GE HealthCare’s chief science and technology officer. “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 ground-breaking technology that transforms healthcare and enhances patient outcomes,”.
 
The list of 72 GE HealthCare 510(k) nods or authorizations includes those from recently acquired companies, BK Medical, Caption Health, and MIM Software. Some examples include:

• Precision DL deep learning-based image processing software for small, low-contrast lesion detectability
• Contour Protégé software (from MIM Software) to automatically generate contours for radiation oncology treatment planning
• Caption Interpretation automatic ejection fraction software (from Caption Health) to process previously acquired transthoracic cardiac ultrasound images, store the images, manipulate them, and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system
• bkActiv (from BK Medical) for high-resolution images and anatomical details to visualize structures and perform confident surgeries. It includes Prostate Volume Assist, an AI software feature to automate generation of prostate volume measurements