FDA clears Sony to sell smart operating room in USA
February 11, 2020
Sony Electronics has received FDA 510(k) clearance to sell its Nucleus smart operating room in the USA.
The imaging management and collaboration control platform has proven itself in Europe with more than 500 operating room installations at hospitals in the UK, Belgium, Sweden and other locations. Sony is now cleared to begin the marketing and sales of the network-based platform in the USA 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 USA 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 on-going development of unique smart applications, Nucleus will continue to push the boundaries of what is possible in the OR."
Nucleus can provide 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. It is a software-based platform that reduces room hardware requirements.
Scalable, it can be 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.
There is support for third-party applications via APIs and a variety of mechanisms and tools. It has secure HIS integration, and is HL7 and Dicom compliant.
Sony Electronics is a US subsidiary of Japanese firm Sony and is headquartered in San Diego, California.