GE HealthCare Announces the FDA Clearance of nCommand Lite by IONIC Health

2024-03-25

GE HealthCare to exclusively distribute nCommand Lite by IONIC Health for multi-vendor, multi-modality remote operations capabilities CHICAGO--(BUSINESS WIRE)-- GE Healthcare (Nasdaq: GEHC) announces the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology. The vendor-agnostic, multi-modality nCommand Lite system will be distributed exclusively by GE HealthCare and will provide remote patient scanning support, remote access for viewing/review of images*, as well as the ability to connect to remote experts who can provide real-time guidance to the licensed technologist operating the scanner. Off-site experts can use these features to aid in training, procedure assessment and scanning parameter management. IONIC Health’s nCommand Lite includes multi-modality capabilities in support of magnetic resonance (MR), computed tomography (CT), and positron emission tomography/CT (PET/CT) scanning. A recent study found that 80% of radiology departments are suffering from staff shortages.i Additionally, the most recent 2023 American Society of Radiologic Technologists (ASRT) Radiologic Sciences Staffing and Workplace Survey found that vacancy rates are the highest they have been since the survey was initiated in 2003.ii Health systems grappling with operational challenges and workforce shortages are increasingly looking for innovative solutions to increase their flexibility in staffing, scheduling, and operational structure to better meet the growing needs of their patient population. GE HealthCare offers multiple solutions to streamline workflows, increase efficiency, and ease the burden of staff shortages, including effortless operations to assist with remote scanning, training, protocol management, and collaboration. To further enhance its remote operations portfolio, GE HealthCare launched an FDA-cleared new version of Digital Expert Access and announced an exclusive distribution agreement with IONIC Health in November 2023. “GE HealthCare is committed to continued investment in the rapidly growing space of remote operations through innovation and strategic collaborations that support the current and future needs of healthcare institutions. Our goal is to provide remote operations solutions that lead to increased access for patients, including patients who may require complex care and support from an off-site expert technologist,” said Rekha Ranganathan, senior vice president, general manager, Imaging Platforms and Digital Solutions, GE HealthCare. “Additionally, we recognize that healthcare systems are not only looking to leverage the skills of one expert across multiple physical locations for knowledge sharing and training but have an imaging fleet that includes multiple vendors and modalities, so it was critical for us to expand our remote operations portfolio by adding IONIC Health’s nCommand Lite technology.” The nCommand Lite system is designed to enable off-site experts to remotely provide real-time guidance to the licensed technologist operating the scanner and includes vendor-agnostic, multi-modality capabilities, offering a differentiated remote scanning solution that helps streamline workflow across disparate imaging fleets. Additionally, a remote user can be connected to multiple scanners, and the technology is designed for low bandwidth consumption for an optimized user experience, enabling seamless collaboration. “We are thrilled that our nCommand Lite solution, built on the three-year-strong nCommand platform from Brazil, is now cleared for use in the U.S.,” said José Leovigildo Coelho, CEO and co-founder of IONIC Health. “Developed with multi-modality and multi-vendor functionalities and high-end technology to scale and tackle staffing shortages, nCommand Lite enables broader access to expert technologists. Through our continued collaboration with GE HealthCare, we hope to make the nCommand technology available to more regions across the globe in the future.” *Images reviewed remotely are not for diagnostic use. ### About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with 51,000 colleagues working to create a world where healthcare has no limits. Follow us on Facebook, LinkedIn, Twitter, Instagram, and Insights for the latest news, or visit our website for more information. About IONIC Health Pioneering the diagnostic medicine technology sector, IONIC Health has become the first Brazilian company to secure U.S. FDA clearance for a multi-vendor, remote access technology for medical imaging devices. Known as nCommand Lite, this technology facilitates real-time remote guidance, scanning, support, and training for healthcare professionals. The company has locations in São José dos Campos, Brazil; Cleveland, Ohio-U.S.; and Porto, Portugal. These sites support IONIC Health's operations in Brazil, the United States and Europe. IONIC Health is committed to expanding its reach worldwide, improving access to healthcare technology. i PANNER, MORRIS. “Minding the Gap: Strategies to Address the Growing Radiology Shortage.” Imaging Technology News, July 13, 2023. . ii American Society of Radiologic Technologists (ASRT), “2023 Radiologic Sciences Workplace Staffing Survey”, Product ID: 23501