GE HealthCare tops FDA list for AI-enabled medical devices for fourth year in a row

GE Healthcare tops FDA AI list: ©Infiniteflow - stock.adobe.com

GE HealthCare has again claimed the top spot on the U.S. Food and Drug Administration’s list of AI-enabled medical device authorizations, marking the fourth consecutive year the company has led in this category. With 100 FDA-listed authorizations to date, GE HealthCare continues to build on its efforts to integrate artificial intelligence across its portfolio of imaging and diagnostic tools, according to the company.

The milestone reflects the company’s strategic focus on AI-powered innovation to advance precision care, streamline workflows, and improve patient outcomes. GE HealthCare said the success is tied to high demand for smart devices and software, which also contribute to increased revenue and long-term growth.

“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 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.”

GE HealthCare’s authorized devices span various care pathways, including oncology, cardiology, and neurology. Among the technologies highlighted:

Auto Positioning uses deep learning to automate patient positioning in CT and PET/CT systems, streamlining technologist workflows with single-click operation.

AIR Recon DL, a deep learning reconstruction algorithm for MRI, enhances image quality and reduces scan times by up to 50%. The company estimates over 50 million patient scans have used the technology since its 2020 launch.

The LOGIQ Series ultrasound systems incorporate AI-powered automation and dynamic anatomy recognition to improve image consistency and diagnostic confidence.

Precision DL, used with the Omni Legend PET/CT system, leverages deep learning to enhance image clarity and diagnostic accuracy, offering performance on par with Time-of-Flight reconstruction.

Venue Family point-of-care ultrasound systems include Caption Guidance™ software, which offers real-time prompts to help clinicians, including new users, capture quality cardiac images.

Kass-Hout emphasized the broader vision: “We’re accelerating the pace of innovation to meet the urgency of today’s healthcare challenges. Reaching this milestone is also an important step along our journey of evolving from an imaging company to a health care solutions provider, enabling us to deliver holistic and integrated solutions that meet our customers’ needs today and will help enable them to stay ahead in a rapidly evolving health care environment.”

GE HealthCare said its innovation efforts span the product lifecycle—from early-stage research and development to commercialized offerings—and frequently involve collaborations with top medical institutions, universities, and tech firms.

“As we continue to drive the industry forward, we remain committed to doing so in a responsible way, building in our Responsible AI principles at every stage of our product development which include a focus on safety, validity, transparency, explainability, and fairness,” Kass-Hout added.

GE HealthCare aims to double its current FDA AI-enabled authorizations, targeting more than 200 as part of its ongoing transformation and growth strategy.