Sony’s smart OR platform gains FDA clearance

Sony Electronics has received FDA 510(k) clearance from the Food and Drug Administration for the company's NUCLeUS™ Operating Room, Imaging Management and Collaboration Control platform.

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Open and flexible, the system accommodates changing requirements, keeping pace with latest imaging workflow innovations and making the best use of existing network infrastructure without additional costs.
Source: Sony Electronics

Proven in Europe with more than 500 operating room installations at leading hospitals in the UK, Belgium, Sweden and other locations, Sony is cleared to begin the marketing and sales of the network-based platform in the United States immediately.

Supporting up to 4K resolution using existing network infrastructure, NUCLeUS provides an enhanced, streamlined workflow for operating rooms and clinical spaces with direct access to imaging data from an easy-to-use central dashboard. With secure, managed access, professionals can capture and manage video and audio content in near real-time for collaboration and teaching purposes. "We are eager to put NUCLeUS in the hands of doctors, nurses and OR managers in the U.S. so they can experience first-hand how the platform can dramatically improve surgical collaboration and potentially contribute to better patient outcomes," said Theresa Alesso, president of Sony Electronics' Pro division. "With the ongoing development of unique 'smart applications,' NUCLeUS will continue to push the boundaries of what is possible in the OR."

Capabilities that are a part of NUCLeUS include:

  • providing hospitals with a secure, encrypted means of recording, archiving, distributing and managing surgical video and other types of medical imaging and patient data without requiring expensive network infrastructure upgrades
  • a software-based platform that greatly reduces room hardware requirements
  • fully scalable solution that can be easily extended to serve additional rooms or hospital buildings at any time
  • smart applications and additional optional features can be added remotely as they are released
  • support for third-party applications via APIs and a variety of mechanisms and tools
  • secure HIS integration, fully HL7 and DICOM compliant
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