GE HealthCare Announces New Version of Digital Expert Access, the First FDA 510(k)-Cleared Device to Enable Remote Patient Scanning, and Exclusive Distribution Agreement with IONIC Health

Rhea-AI Summary

GE HealthCare (GEHC) has received U.S. FDA 510(k) Clearance for the new version of Digital Expert Access with remote scanning, a first-of-its-kind solution that enables remote patient scanning. The collaboration with IONIC Health aims to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems globally, addressing the shortage of radiologists and operational efficiency challenges.

Positive

• First remote patient scan solution with 510(k) Clearance
• Exclusive distribution agreement with IONIC Health for multi-vendor, multi-modality remote scanning capabilities
• Strategic collaboration to address radiologist shortage and operational efficiency challenges

Negative

• None.

IONIC Health will add multi-vendor, multi-modality remote scanning capabilities to GE HealthCare's portfolio of effortless operations solutions, including the recently FDA-cleared Digital Expert Access with remote scanning.

CHICAGO--(BUSINESS WIRE)-- GE HealthCare (Nasdaq: GEHC) has received U.S. FDA 510(k) Clearance for the new version of Digital Expert Access with remote scanning, the first remote patient scan solution with 510(k) Clearance. Digital Expert Access enables the sharing of expertise, best practices, and in-the-moment advice, as well as real-time, remote console control. Now, with the new version of Digital Expert Access with remote scanning, this innovative solution has evolved to also enable remote patient scanning, which is compatible with GE HealthCare magnetic resonance (MR) devices.

Additionally, GE HealthCare has entered into an exclusive distribution agreement with IONIC Health, an independent Brazilian-born global technology company transforming healthcare through novel automation technologies, which include remote solutions to automate, monitor, access, support, educate and teleoperate in healthcare. IONIC Health’s 510(k)-pending nCommand Lite technology is designed to include vendor-agnostic remote scanning capabilities. This strategic collaboration’s goal is to enable GE HealthCare to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems and patients around the globe.ⁱ

In a modern radiology practice, clinicians are required to manage a fast-growing number of imaging procedures and imaging experts are in especially short supply and high demand. Cost pressures and resource scarcity have also intensified the need for greater collaboration across multiple sites of service and the migration of diagnostic imaging beyond hospital campuses. Consequently, patients can experience long wait times or rescheduled appointments due to limited imaging resources, potentially disrupting their care and prolonging the timeline from scan to diagnosis and treatment. A survey of 1,125 radiology department [leaders/administrators] revealed that the main challenge in radiology departments over the next 1-3 years is anticipated to be operational efficiency (73%).ⁱⁱ Additionally, the Association of American Medical Colleges (AAMC) projects a shortage of up to 41,900 radiologists in the United States in 2033.

GE HealthCare offers solutions to streamline workflows and increase efficiency including effortless operations to assist with remote scanning, training, protocol management, and collaboration. Digital Expert Access is a real-time, virtual solution that enables collaboration among radiology teams, within a single hospital or across multiple locations. It allows clinicians to easily share expertise, best practices, and advice or remotely access key controls in the scan room to provide immediate help. The new version of Digital Expert Access with remote scanning introduces a feature that enables the remote clinical expert user to initiate a scan on GE HealthCare MR devices from locations inside or outside of the radiology suite or any clinical facility, as long as aligned with respective regional regulations and safety guidelines.

“The ability to seamlessly bridge multiple locations, users, and devices, enables technologists to share knowledge, improves exam workflows, speeds up decision-making and helps achieve clinical and efficiency goals. With a shortage of radiologists, it is also key for facilities to be able to leverage the skills of one expert across multiple physical locations,” said Jan Makela, president and CEO of Imaging, GE HealthCare. “Additionally, as the first FDA-cleared remote scan solution, Digital Expert Access with remote scanning sets a new bar for patient safety within imaging operations, which is critical given the anticipated future growth within this space.”

To further enhance remote operations, GE HealthCare has entered into an exclusive distribution agreement with IONIC Health. The nCommand Lite system by IONIC Health is a 510(k)-pending technology designed to remotely provide real-time guidance to the licensed technologist operating the scanner.* Additionally, it is intended to offer multi-vendor and multi-modality capabilities, including MR, computed tomography (CT) and positron emission tomography (PET) - CT, enabling a differentiated remote scanning solution which will help optimize workflow across disparate imaging fleets. This new collaboration demonstrates GE HealthCare’s ongoing dedication to shaping the future of healthcare through innovation and strategic collaborations that streamline workflow and increase operational efficiency, ultimately helping enhance patient care and outcomes.

“We recognize the need for differentiated multi-vendor compatible technology that can provide flexibility and seamless workflow integration to busy clinicians,” said Rekha Ranganathan, senior executive, general manager, Imaging Platforms & Digital Solutions, GE HealthCare. “The overarching goal of the new version of Digital Expert Access and our collaboration with IONIC Health is to help healthcare systems increase efficiency and shorten the timeline to diagnosis for patients, which is a critical component in improving outcomes.”

“This exclusive distribution agreement will enable greater and accelerated future access to remote operations and scanning capabilities to healthcare systems, clinicians, and patients,” said José Leovigildo Coelho, CEO and co-founder of IONIC Health. “The current healthcare landscape, which includes dire radiologist shortages, highlights the immense immediate and long-term need for remote operations and we are thrilled that GE HealthCare recognizes the role that this innovative technology will play in streamlining the patient journey and improving care for many years to come. At the core of IONIC lies our mission to export Brazilian technology that creates a lasting, positive impact in the world through healthcare. We couldn’t have found a better collaborator to accomplish this.”

For more information on remote operations and scanning, visit the GE HealthCare (#7326) booth at the Radiological Society of North America 2023 Annual Meeting.

*nCommand Lite is 510(k)-pending at the U.S. FDA. Not available for sale in the U.S. Availability in other markets is subject to local regulatory approvals.

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 an $18.3 billion business with 50,000 employees 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

Established in 2015, IONIC Health, headquartered at the São José dos Campos Technological Innovation Park in São Paulo, is a Brazilian company driven by healthcare, automation, and innovation. With a team of over 150 professionals, including radiologists, technologists, computer scientists, software developers, statisticians, researchers, AI specialists, and health experts, IONIC Health is a recognized pioneer in the diagnostic medicine sector. The company's entrepreneurial spirit and results-oriented tech mindset have led to the development of several automation products. Notably, IONIC Health is at the forefront of multi-vendor remote access technology for medical imaging devices, enabling real-time remote guidance, scanning, support, and training for healthcare professionals. Serving over 50 clients in Brazil and with recent international expansion in Europe and the United States, IONIC Health is dedicated to scaling globally and enhancing healthcare technology infrastructure.

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ⁱ nCommand Lite is 510(k)-pending at the U.S. FDA. Not available for sale in the U.S. Availability in other markets is subject to local regulatory approvals.
ⁱⁱ GE HealthCare data and market research.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231121879111/en/

GE HealthCare Media Contact:

Karin Dalsin

Global Communications Director

M 612.219.2855

karin.dalsin@ge.com

Source: GE HealthCare

FAQ

What is the significance of GE HealthCare's new version of Digital Expert Access with remote scanning for healthcare systems?

The new version of Digital Expert Access with remote scanning is the first remote patient scan solution with 510(k) Clearance, addressing the shortage of radiologists and operational efficiency challenges.

What is the goal of GE HealthCare's exclusive distribution agreement with IONIC Health?

The goal is to provide a multi-vendor, multi-modality remote scanning solution to healthcare systems globally, aiming to streamline the patient journey and improve care.

What challenges does the collaboration between GE HealthCare and IONIC Health aim to address?

The collaboration aims to address the shortage of radiologists and operational efficiency challenges in healthcare systems globally.

What is the main feature of the new version of Digital Expert Access with remote scanning?

The main feature is the ability to initiate a scan on GE HealthCare MR devices from locations inside or outside of the radiology suite, improving exam workflows and decision-making.

Why is the new version of Digital Expert Access with remote scanning significant for healthcare systems?

It helps bridge multiple locations, users, and devices, enabling technologists to share knowledge, improve exam workflows, and achieve clinical and efficiency goals.