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

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GE HealthCare, listed on Nasdaq as GEHC, has secured exclusive distribution rights for IONIC Health's nCommand Lite technology, following FDA clearance. The system enables remote patient scanning support, image viewing, and real-time guidance from experts across various modalities. This move addresses the industry's staffing shortages and operational challenges, offering innovative solutions for healthcare providers.
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The FDA 510(k) clearance for IONIC Health's nCommand Lite technology represents a significant advancement in the medical imaging field. This clearance allows GE HealthCare to distribute a system that facilitates remote patient scanning support and expert consultation, which is particularly important in addressing current radiology department staffing shortages. The technology's vendor-agnostic nature means it can be integrated into various existing systems without being confined to a single manufacturer's devices, potentially broadening its market appeal.

The integration of this technology into GE HealthCare's product lineup could lead to increased efficiency in medical imaging departments. By enabling remote access and assistance, nCommand Lite could reduce the need for on-site expert presence, which in turn may lower operational costs and improve patient throughput. This is particularly relevant in the context of the reported 80% staffing shortages in radiology departments and the highest vacancy rates since 2003 according to the ASRT survey.

In the long term, the adoption of such remote operation technologies could transform the operational structure of health systems, leading to a more flexible and potentially global workforce. However, the benefits must be weighed against concerns about data security, reliance on internet connectivity and the need for robust training to ensure effective use of the technology.

The exclusive distribution deal between GE HealthCare and IONIC Health for the nCommand Lite system could have a notable impact on GE HealthCare's market position. By offering a solution to the pressing issue of radiology staff shortages, GE HealthCare is positioning itself as a leader in innovative healthcare solutions. This strategic move could potentially enhance the company's reputation and drive sales within the healthcare technology sector.

From an industry perspective, the adoption of remote imaging technologies like nCommand Lite is likely to accelerate, given the increasing demand for healthcare services and the ongoing workforce challenges. This trend may encourage competitors to invest in similar technologies or partnerships, leading to a more competitive landscape. GE HealthCare's early mover advantage could be a critical factor in capturing market share and establishing long-term customer relationships.

Investors should monitor the adoption rate of nCommand Lite and its impact on GE HealthCare's financial performance. Success in this venture could lead to upward revisions of revenue forecasts and potentially influence stock valuations. Conversely, any technical or adoption challenges could temper expectations and impact investor sentiment.

The FDA 510(k) clearance of nCommand Lite underscores the regulatory support for telehealth and remote medical technologies. This decision aligns with broader healthcare policy trends aimed at improving access to care and mitigating workforce challenges. By facilitating remote operations, this technology could help alleviate some of the pressures on healthcare systems, especially in underserved areas where access to expert radiologists is limited.

Policy implications of such technologies extend to the potential for regulatory changes to accommodate the evolving nature of healthcare delivery. Ensuring that these systems adhere to patient privacy laws and maintain high standards of care will be essential. The healthcare industry and policymakers may need to collaborate on developing guidelines for the safe and effective use of remote operation technologies.

While the immediate impact of nCommand Lite on healthcare policy may be limited, its long-term influence on shaping regulatory frameworks for telehealth cannot be underestimated. It's important to monitor how these advancements are integrated into healthcare systems and the resulting policy responses to ensure they contribute positively to patient outcomes and healthcare efficiency.

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.

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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 https://www.gehealthcare.com/ 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. https://www.itnonline.com/article/minding-gap-strategies-address-growing-radiology-shortage.

ii American Society of Radiologic Technologists (ASRT), “2023 Radiologic Sciences Workplace Staffing Survey”, Product ID: 23501

GE HealthCare Media Contact:

Karin Dalsin

Global Communications Director

M 612.219.2855

karin.dalsin@gehealthcare.com

Source: GE HealthCare

FAQ

What technology has GE HealthCare gained exclusive distribution rights for?

GE HealthCare has secured exclusive distribution rights for IONIC Health's nCommand Lite technology.

What capabilities does the nCommand Lite system offer?

The nCommand Lite system provides remote patient scanning support, image viewing, and real-time guidance from experts in various modalities.

What percentage of radiology departments are currently facing staff shortages?

A recent study found that 80% of radiology departments are suffering from staff shortages.

What survey highlighted the highest vacancy rates in radiologic technologists?

The 2023 American Society of Radiologic Technologists (ASRT) Radiologic Sciences Staffing and Workplace Survey reported the highest vacancy rates since 2003.

What challenges are health systems currently grappling with?

Health systems are facing operational challenges and workforce shortages, leading to a need for innovative solutions to enhance flexibility in staffing, scheduling, and operational structure.

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