TrueVision Announces Approval for its 3D Visualization and Guidance System for Microsurgery in Major Asian Markets
Partners in Japan, China, and Korea launch sales and marketing for TrueVision 3D visualization and guidance surgical technology
TrueVision® Systems, Inc. today announced it is approved to sell and market the TrueVision® 3D Visualization and Guidance System for Microsurgery in several major Asian markets. Regulatory registration and approval was granted in China (SFDA, State Food and Drug Administration), Japan (Japanese PAL Japanese Pharmaceutical Affairs Law – Todokede Market Approval Process), and Korea (KFDA, Korean Food & Drug Administration).
“TrueVision conforms to medical device standards including EN 60601-3 Third Edition, ISO 13485, and ISO 9001:2008.” says Connor McCarty, RAC, Product Management and Regulatory Affairs. This has facilitated our regulatory registrations in North America, Europe and now major regions in Asia.”
“The Asian markets, particularly China, are ready for explosive growth for new technologies such as TrueVision with regulatory approval that also offers improved surgical efficiencies and outcomes. We are very well positioned with excellent market partners in each region.” says Forrest Fleming CEO.
TrueVision has teamed with leading sales organizations in Asia to open up these new markets;
China: – Wego TrueVision 3D Surgical Joint Venture has teamed up with Global Vision for sales in the ophthalmic space
Japan: – TrueVision has teamed up with Toyo Medic Co., Ltd for sales in the neurosurgical space,
South Korea: – TrueVision has teamed up with Medicare Korea for sales in all microsurgical vertical markets including neurosurgery, ophthalmology, ENT and spine.
TrueVision® 3D Visualization and Guidance System is a stereoscopic 3D high-definition visualization system that displays the surgical field of view in real-time on 3D flat-panel displays in the operating room. The company is also developing a suite of 3D guidance applications for the platform. These enable the surgeon to operate “heads up” by looking at a large screen with navigation templates fused into the live image, providing better ergonomics and a more immersive visualization experience for the surgeon and staff. The system is also used to record 3D surgical video for educational purposes and presenting on-demand and streaming 3D surgical video content at medical meetings.