GE Healthcare tops list with most AI-enabled device approvals, more than any other medtech company

GE Healthcare tops list with most AI-enabled device approvals, more than any other medtech company

Of the more than 500 devices included by the US FDA on a recently updated list of AI-enabled device approvals, 42 are from GE Healthcare, a milestone that highlights the impact of the company’s digital strategy. ‘company.

CHICAGO, October 20, 2022–(BUSINESS WIRE)–On a recently updated FDA list of artificial intelligence (AI)-enabled medical devices, GE Healthcare held the most approvals, with 42 510(k) clearances listed to date, in the United States.

This reflects the execution of the company’s AI strategy, which is centered on solving three of healthcare’s biggest challenges: efficiency and access to the healthcare system, healthcare, as well as system interoperability and workflow integration.

GE Healthcare’s cutting-edge AI strategy includes Edison Health Services. Edison Health Services is GE Healthcare’s software technology designed to aggregate data from multiple sources and providers to enable clinical applications that support integrated management of care pathways and holistic views of each patient. It is designed to be vendor-neutral and can include a healthcare-specific AI toolkit to build and run applications.

“The future of healthcare is about harnessing raw data and using it to help clinicians provide better patient care. For AI to be effective, it must be seamless and within existing workflows, while uncovering patterns that complement those generated by humans,” said Vignesh Shetty, Senior Vice President and General Manager, Edison AI & Platform, GE Healthcare. “GE Healthcare’s digital strategy is to turn to AI to help clinicians achieve clinical and operational outcomes that create maximum impact for patients, providers and healthcare systems. From large iron MRI scanners used by doctors to detect tumors on the prostate to mobile X-rays in the ER or ICU that technicians use to image the lungs of COVID patients at their bedside, we are seeing tangible impact with our AI embedded on the device where and when clinicians need it. AI is an incredible lever for solving problems at the speed and scale our providers expect, to help save lives and improve outcomes for millions of patients around the world. »

The FDA’s Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices webpage provides a list of devices that have been cleared by the FDA via 510(k) clearance, granting applications De Novo or through pre-market approval (PMA). The list includes 42 GE Healthcare 510(k) clearances for AI-powered and data-driven solutions across the company’s extensive product portfolio. These products are designed to help encourage greater confidence in diagnoses across multiple care pathways such as oncology, cardiology and neurology, helping to ease the burden of care and improve workflows for health systems around the world. Examples include:

  • Air Recon DL delivers breakthrough MR imaging with its deep learning-based image reconstruction algorithm. The technology is incorporated into a number of products, including Signa Premier and Signa Hero.

  • Critical Care Suite 2.0 offers a premier collection of AI algorithms embedded on a mobile X-ray device for case prioritization, automated measurements, and quality control. Its AI algorithm helps clinicians assess endotracheal tube (ETT) locations and care for critically ill patients who require ventilation. AMX Navigate is a portable X-ray technology featuring Critical Care Suite 2.0, a Zero Click Exam workflow solution and an assisted free-motion telescoping column.

  • Liver ASSIST virtual parenchyma1 is a 3D visualization software solution designed to provide AI-powered virtual parenchymography to help clinicians dynamically simulate injections and perform liver embolization procedures with confidence.

  • Voluson 22 is a women’s health ultrasound system that provides enhanced image quality and specialized clinical tools to help see more anatomical detail with greater certainty and enable the best possible patient care.

  • Revolution Ascension is a 75cm large-diameter CT system designed to make the CT process faster, more intuitive, and more accessible, while delivering the image quality that clinicians expect. The product uses an AI-powered workflow solution, smart user interface, advanced technology, and access to Smart Subscription to help simplify, streamline, and automate the CT experience.

For more information on GE Healthcare’s AI-enabled medical device solutions, visit here.

About GE Healthcare:

GE Healthcare is the $17.7 billion healthcare business of GE (NYSE: GE). As a global leader in medical technology, pharmaceutical diagnostics and digital solutions innovation, GE Healthcare empowers clinicians to make faster, more informed decisions through smart devices, data analytics, apps and services, supported by its Edison Health Services software platform. With more than 100 years of experience in the healthcare industry and approximately 48,000 employees worldwide, the company operates at the center of an ecosystem driving precision health, digitizing healthcare, helping to drive the productivity and improve outcomes for patients, providers, health systems and researchers around the world.

follow us on Facebook, LinkedIn, Twitter, instagram and Knowledge for the latest news, or visit our website for more information.

1 Liver ASSIST Virtual Parenchyma solution includes Hepatic VCAR and FlightPlan for Liver with Parenchyma Analysis and requires AW workstation with Volume Viewer, Volume Viewer Innova, Vision 2, VesselIQ Xpress, Autobone Xpress.

See the source version on


Kathleen Crean
(414) 779-3374

#Healthcare #tops #list #AIenabled #device #approvals #medtech #company

Leave a Comment

Your email address will not be published. Required fields are marked *