![]() "We also look forward to working with nView to expand application of this technology for use in cervical spine procedures, utilizing Orthofix cervical solutions." It is an innovative digital solution aimed at better streamlining the surgery by reducing radiation exposure and decreasing OR time, which is so important for pediatric surgeons and their patients," said Orthofix President and Chief Executive Officer Jon Serbousek. "The nView s1 system’s insta-3D imaging technology complements Orthofix’s pre-planning and post-operative software platforms. Additionally, the companies will pursue the development of an application of the technology for adult cervical spine procedures utilizing Orthofix’s comprehensive portfolio of cervical solutions. Orthofix and nView medical will work together to gain 510(k) clearances for Orthofix pediatric limb deformity solutions navigated with the nView s1 system. The nView s1 doubles up as a surgical guidance system with GPS-like technology that uses the true representation of the anatomy as maps and incorporates AI technology to augment the surgeon’s understanding of the surgery.Īs part of the collaboration, Orthofix will utilize an nView s1 imaging and navigation system in its Lewisville, Texas training facility where they will conduct joint educational programs for surgeon customers. This approach makes the 3D images available throughout surgery, enabling real time visualization. Food and Drug Administration 510(k) cleared imaging system that features the unique ability to instantly capture 3D images with very low-dose radiation. What is the next milestone for your device?Ĭlinical validation followed by a 510(k) submission.The novel nView s1 ™ system with insta-3D ™ technology is a U.S. $250,000 Small Business Loan from the North Carolina Biotechnology Center $1.8M in federal & state grant, with seed money from two angel investors. Product is currently in validation testing and expected to launch in 4Q17 We are performing cadaver lab testing of our device. Our product is geared to the in-office hysteroscopist with an all-in-one system for under $6000 The EndoSee device is useful for only diagnostic procedures (no therapeutic capabilities) and no outflow fluid management, with less visualization due to the small screen. EndoSee Medical, now a part of Cooper Surgical, is the only other targeted, office-based product. Tower systems that cost $30,000 plus licensing and servicing contracts are currently available but financially prohibitive. This is the only x-ray scanner capable to do intra-operative 3D imaging with real-time performance, allowing surgeons to use it for intra-operative imaging and image guidance. How does your product differ from the competition? Female cystoscopy will also be able to be performed with the current scope system. UVision's hysteroscopy system enables office-based gynecological procedures such as diagnostic hysteroscopy, directed biopsy, fallopian tubal occlusion for permanent sterilization using currently marketed devices, and other outpatient surgical procedures that are currently performed in the ASC or hospital setting. The system works with off-the-shelf monitors and computer systems. The operative channel enables therapeutic procedures that can be done in the office. This allows gynecologists to perform global hysteroscopic procedures with superior visualization due to our high-definition optics and integrated flow system. UVision360 offers an all-in-one office system with a patented rotatable cannula providing a 360°, 30-mm depth of view, high-definition optics, integrated fluid management, and an operating channel. The system includes a reusable slim-line hysteroscope and our unique disposable 360° cannula. ("UVision") is focused on the simplification of hysteroscopic systems, especially for the office setting. ![]() We are targeting spine surgery for our beachhead market because of the high rate of revisions due to misplaced screws. We are developing a scanner capable to provide instantaneous 3D imaging during surgery, allowing surgeries to be safer, faster and consistently accurate. Describe your device and how it will benefit healthcare.
0 Comments
Leave a Reply. |
Details
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |