May 21, 2020 — NucleusHealth, a provider of cloud-based medical image management technology and teleradiology services, announced today that it has received Conformité Européene (CE) Mark approval for Nucleus.io. The CE marking confirms that Nucleus.io, a suite of solutions that provides secure accessibility of medical images to improve workflows and speed patient care, meets the requirements of the European Medical Devices Directive (MDD). This now allows NucleusHealth to commercialize Nucleus.io across the European Union and other CE Mark geographies.
“We’ve had great success with using the cloud and our proprietary streaming capabilities to help streamline the viewing, storing and sharing of medical images in the U.S.,” said Claude Hooton, President and Chief Operating Officer of NucleusHealth. “We are very excited about now having the opportunity to provide value outside the U.S. as well.”
The company launched Nucleus.io, its second-generation image management platform, to provide a more robust system that could serve as an organization’s full picture archiving communications system (PACS), which earned its FDA 510(k) clearance in May of 2017. The Nucleus.io platform is positioned to serve the collaborative nature of the imaging community with hopes of facilitating innovative use-cases that accelerate patient care globally, as it has with U.S.-based facilities. Now, with both CE Mark approval and FDA 510(k) clearance, Nucleus.io can be seamlessly integrated into interoperability initiatives at major hospitals across the U.S. and Europe.
The deployment of Nucleus.io removes accessibility roadblocks that many in the imaging community face. The benefits of image-enabling clinical workflows can be realized with time and cost savings that lessen strain on administrative staff, burden on IT teams, and frustration for physicians and patients alike. Organizations can offer patients control of their own health data and empower them to take an active role in their care, while equipping clinicians with a secure tool for collaborating and interacting with images from end-to-end.
“As we’ve seen an increase in the use of telemedicine during the COVID-19 crisis, it has become clear that healthcare no longer has geographical boundaries. We will eventually be able to seamlessly share images across the globe with no delays due to latency or other historical hurdles,” said Hooton. “We are looking forward to connecting communities around the world.”
Technology licensing opportunities are now available in the EU for Nucleus.io exclusively as a web-scale platform-as-a-service (PaaS) with target geographies to be determined based on the needs of interested partners. Nucleus.io software-as-a-service (SaaS) solutions that include Nucleus Dx (diagnostic workstation), Nucleus iX (image exchange), and Nucleus iS (infinite storage) are expected to become available in the European Union in early 2021.
For more information: www.nucleushealth.io
April 22, 2024 
