SAN JOSE, Calif.--(BUSINESS WIRE)--NDS Surgical Imaging (NDSsi) today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ZeroWire® Duo, a Class II medical-grade wireless Full HD video solution for minimally-invasive surgery, GI and interventional suites. With 510(k) clearance, NDSsi is now able to offer this advanced technology, customizable solution that meets the video transmission challenges of the operating room to customers in the United States.
“With the announcement of today’s FDA clearance, NDSsi couldn’t be more excited. We have received many requests for a reliable wireless HD product for the operating room,” said John Murphy, President and CEO of NDSsi. “We are now able to offer our customers in the U.S. a wireless HD solution designed specifically for the operating room that has a unique ability to provide clinical efficiency and enhance safety in the OR.”
The ZeroWire system provides reliable communication with less than 1 frame latency and the image quality required for today’s multi-modality imaging environments, delivering full high-definition surgical video in real-time utilizing the UWB frequency spectrum. This wireless system has been developed to improve clinical efficacy and safety by eliminating downtime from disconnected or damaged cables and reducing the cleaning time between procedures.
“With the increased demands on ORs, hospitals are continuously looking for reliable technology solutions that improve clinical efficacy while adding to the hospital’s bottom line,” said Jens Ruppert, Vice President, Surgical Business Unit, NDSsi. “We are very excited about being able to now offer ZeroWire in the U.S., as this product provides many benefits to the OR including lower installation costs, accelerated turn-around time, and greater flexibility during clinical procedures.”
Some of the features and benefits of the ZeroWire Duo HD Wireless Video Transmission System include:
Memory-enabled pairing system that makes installation quick and easy
Medical grade image quality with full high-definition video (1080p60)
Ultra-low latency of less than 1 frame for real-time surgical video
Designed and tested in accordance with applicable standards to not interfere with other equipment in the OR
Signal reliability by virtue of UWB radio technology
Interfaces with a wide range of image sources and surgical monitors in the OR
As a medical visualization innovator, NDSsi strives to enable new clinical imaging solutions and fuel collaborative medicine. ZeroWire is central to this mission as a core platform within the company’s Medical Visualization Informatics (MVI) offering, which helps drive procedural efficacy in the OR by offering the unique ability to connect the realms of PACS imaging, surgical video and medical informatics.
For more information on NDSsi’s ZeroWire video solution, please visit our website http://www.ndssi.com/zerowire.
About NDS Surgical Imaging
NDS Surgical Imaging (NDSsi) provides visualization systems that enable medical and surgical imaging solutions from the radiology reading room to the OR, endoscopy and interventional suites. NDSsi products have revolutionized medical imaging applications for more than a decade.
As the company continues to move into the future, the core focus remains to deliver cutting-edge visualization display products and informatics appliances that enable new clinical imaging solutions and fuel collaborative medicine. NDSsi is a privately-held company with its headquarters, R&D and manufacturing based in San Jose, California, and regional offices in Europe and Asia-Pacific. The company has a global presence with over 200,000 systems installed in more than 35 countries worldwide. For more information, visit www.ndssi.com.
