Sony Announces FDA Clearance for NUCLeUS, the Smart Operating Room Platform, for Sale in the U.S.

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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.

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

About Sony Electronics Inc.

Sony Electronics is a subsidiary of Sony Corporation of America and an affiliate of Sony Corporation (Japan), one of the most comprehensive entertainment companies in the world with a portfolio that encompasses electronics, music, motion pictures, mobile, gaming, robotics and financial services. Headquartered in San Diego, California, Sony Electronics is a leader in electronics for the consumer and professional markets. Operations include research and development, engineering, sales, marketing, distribution and customer service. Sony Electronics creates products that innovate and inspire generations, such as the award-winning Alpha Interchangeable Lens Cameras and revolutionary high-resolution audio products. Sony is also a leading manufacturer of end-to-end solutions from 4K professional broadcast and A/V equipment to industry-leading 4K and 8K Ultra HD TVs. Visit www.sony.com for more information.