On a recently updated FDA list of artificial intelligence (AI) enabled medical devices, GE Healthcare had the highest number of authorizations, with 42 listed 510(k) clearances to date, in the United States. This reflects execution on the company’s AI strategy, which is centered on addressing three of healthcare’s largest challenges: health system efficiency and access, health outcomes, and system interoperability and workflow integration, according to GE.

GE Healthcare’s AI strategy includes Edison Health Services, which is GE Healthcare’s software technology that is designed to aggregate data from multiple sources and vendors to enable clinical applications that support integrated care pathway management and holistic views of each patient. It is designed to be vendor agnostic and can include a healthcare specific AI toolkit for building and running applications.

“The future of healthcare is harnessing raw data and using it to help clinicians provide better patient care. For AI to be effective, it should be seamless and within existing workflows, while uncovering patterns that complement those generated by humans,” says Vignesh Shetty, senior vice president & general manager, Edison AI & Platform, GE Healthcare.

“GE Healthcare’s digital strategy is to look at AI to help clinicians achieve clinical and operational outcomes that create maximum impact for patients, providers and health systems. From big iron MRI scanners used by doctors to detect tumors on the prostate gland to mobile x-ray units in the ER or ICU that technicians use to image the lungs of COVID patients at their bedside, we are seeing a tangible impact with our AI embedded on the device where and when clinicians need it. AI is an incredible lever to tackle problems at a speed and scale that our providers are coming to expect, to help save lives and improve outcomes for millions of patients everywhere,” Shetty adds.

The FDA’s webpage, Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices, provides a list of devices that have been authorized by FDA via 510(k) clearance, by granting De Novo requests, or by premarket approval. Included in the list are 42 GE Healthcare 510(k) clearances for AI-powered and data-driven solutions across the company’s wide portfolio of products. These products are designed to help encourage greater diagnostic confidence across multiple care pathways such as oncology, cardiology, and neurology, by helping to ease the burden of care and improve workflows for healthcare systems worldwide.