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Sony’s NUCLeUS Announces FDA Clearance

Sony’s NUCLeUS Announces FDA Clearance

NUCLeUS cleared by the FDA and soon be available to US hospitals.

Sony Electronics has received a US Food and Drug Administration (FDA) approval for the company’s NUCLeUS operating room, imaging management and collaboration control platform, on Wednesday.

NUCLeUS is an operating room integration system that allows surgeons to connect with various instruments, screens and other applications on one system. This is an easy-to-use central dashboard that uses 4K resolution to provide operating rooms and clinical spaces with direct access to imaging data.

“We are eager to put NUCLeUS in the hands of doctors, nurses and OR managers in the US 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.

NUCLeUS has been installed in more than 500 operating rooms in Europe, including leading hospitals in the UK, Belgium, Sweden and more locations. Sony has now received FDA 510(k) clearance for the platform to be marketed and sold in the US.


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Some capabilities of NUCLeUS include providing hospitals with secure, encrypted ways to record, archive, distribute and manage surgical videos, medical images and patient data. Furthermore, the software reduces the required hardware in the operating rooms. It also has a secure HIS integration and is fully HL7 and DICOM compliant. Here’s an introduction video by Sony, showing the capabilities of the technology:

Additionally, NUCLeUS enhances educational opportunities. Students are able to connect and learn from the content provided in the software. They are provided with multiple streaming videos and instructors can create a real-time two-way audio discussion that enriches learning capabilities.

Sony Electronics, the makers of NUCLeUS, are a subsidiary of Sony Corporation of America. They are known for their entertainment companies, mobile gaming, robotics and financial services. However, Sony is not new to the medical industry; they are innovators across a broad spectrum of medical devices. They’ve created imaging cameras, monitors, recorders, IP imaging platforms and more.

“With the ongoing development of unique ‘smart applications,’ NUCLeUS will continue to push the boundaries of what is possible in the OR,” said Alesso.