Sony gets FDA clearance for OR integration system

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Sony’s NUCLeUS system received FDA 510k clearance. The OR integration system can display video and information from a number of different cameras and instruments.

Sony received 510k clearance for its NUCLeUS operating room integration system, meant to help surgeons connect allow of the instruments, screens and cameras they use into one device. The tech conglomerate is better known for designing consumer electronics, such as the PlayStation, audio equipment and televisions, but Sony is also applying that expertise to its work in the field of medicine.

NUCLeUS was first developed by Belgian company eSaturnus, which Sony acquired in 2016. The OR system has been well-received in Europe, where is used at more than 500 operating rooms in the UK, Belgium and Switzerland. Some of them include University Hospitals Leuven, a large teaching hospital in Belgium, and Karolinska University Hospital in Sweden.

Now, with clearance from the Food and Drug Administration, Sony can market and sell the system in the U.S.

“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,” Sony Electronics Pro Division President Theresa Alesso said in a news release. “With the ongoing development of unique ‘smart applications,’ NUCLeUS will continue to push the boundaries of what is possible in the OR.”

In busy operating rooms, where every bit of space counts, Sony’s tech allows various monitoring devices and instruments to display to one screen. For example, a heart monitor could be connected to the system, along with a camera connected to a surgical boom. Surgeons can choose to display one video or multiple inputs at once.

Sony says its system can support 4K resolution video and 3D video, giving surgeons a more detailed view of their work during a laparoscopic surgery. The system can also provide hospitals with an encrypted means of recording, archiving and distributing the video. For example, it could be streamed into a classroom outside of the OR for training purposes.

The system can also support third-party applications via APIs. Sony has indicated that it plans to release additional optional features for the system in the future.

Photo credit: Sony



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