Sony Receives U.S. FDA Clearance for Operating Room Imaging Management Platform

With 510(k) clearance, platform streamlines OR and clinical access to imaging data

By Whitney J. Palmer

Sony Electronics announced Wednesday that it received 510(k) clearance from the U.S. Food and Drug Administration for its NUCLeUS™ Operating Room, Imaging Management and Collaboration platform.

NUCLeUS is an open, vendor neutral video-over-IP platform that connects devices, applications, and data to facilitate surgical workflow. It connects to the PACS, hospital information system, operating room planning system, and DICOM worklists to, potentially, improve efficiency.

According to a company press release, NUCLeUS uses an existing network infrastructure to support up to 4K resolution and is designed to enhance and streamline workflow for operating rooms and clinical environments by providing direct imaging data access through a central dashboard. Via the system, providers can also capture and manage video and audio content in real-time.

“We are eager to put NUCLeUS in the hands of doctors, nurses, and OR managers in the [United States] so they can experience first-hand how the platform can dramatically improve surgical collaboration and potentially contribute to better outcomes,” said Theresa Alesso, president of Sony Electronics’ Pro divison in a press statement. “With the ongoing development of unique ‘smart applications,’ NUCLeUS will continue to push the boundaries of what is possible in the [operating room.]”

The system is already in use in more than 500 operating room venues in hospitals throughout Europe, including the United Kingdom, Belgium, and Sweden. Sales within the United States will begin immediately, according to the company.

Based on company information, important characteristics of NUCLeUS include:

  • Secure hospital information system integration, fully HL7 and DICOM compliant

  • Secure, encrypted methods to record, archive, distribute, and manage surgical video and other types of medical imaging and patient data without costly infrastructure upgrades

  • Software-based platform that reduces room hardware requirements

  • Fully scalable solution that can be extended to additional rooms or buildings

  • Remote addition of smart applications and additional optional features upon release

  • Support for third-party applications via APIs and other tools