GE HealthCare Tops AI-Enabled Medical Device Approvals for Third Straight Year

Thursday, May 23, 2024

GE HealthCare has led the U.S. Food and Drug Administration (FDA) list of AI-enabled medical devices, boasting 72 listed 510(k) clearances or authorizations in the United States. GE HealthCare also achieved this top position in 2022 and 2023.

GE HealthCare's strategy is heavily focused on investing in AI and machine learning to support its vision of precision care.

Precision care combines advanced technologies like medical imaging, AI, and molecular diagnostics to provide personalized diagnosis, treatment, and ongoing patient management for the best outcomes.

This approach tackles significant industry issues such as data overload, physician burnout, and real-time operational efficiency by developing AI-driven solutions that improve the delivery of high-quality, precision care.

“GE HealthCare is committed to pushing the boundaries of healthcare innovation through advanced technologies like AI.

“Extensive experience in medical devices, spanning over 125 years, enables us to create solutions that address our customers' most critical challenges. Our leadership in AI-based medical device authorizations reflects our dedication to transforming healthcare and enhancing patient outcomes.”

The FDA’s webpage on Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices lists devices authorized through 510(k) clearances, De Novo requests, or premarket approval (PMA). GE HealthCare has 72 devices on this list, including those from recent acquisitions like BK Medical, Caption Health, and MIM Software. Notable examples include:

  • Precision DL: A deep learning-based image processing software that improves the detectability of small, low-contrast lesions compared to traditional Time-of-Flight PET/CT scanners.
  • Contour ProtégéAI+ (MIM Software): Automatically generates contours for radiation oncology treatment planning, reducing the time from simulation to treatment. These contours can be edited if necessary by dosimetrists or physicists.
  • Caption Interpretation Automated Ejection Fraction Software (Caption Health): Processes previously acquired transthoracic cardiac ultrasound images, stores and manipulates them, and provides automated estimation of left ventricular ejection fraction, assisting clinicians in cardiac evaluations.
  • bkActiv (BK Medical): Delivers high-resolution images with detailed anatomical visualization for confident surgical procedures. It includes Prostate Volume Assist (PVA), an AI feature that automates prostate volume measurements, and is also available on the bk3000/5000 and bkSpecto active imaging systems.


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