7D Surgical Announces CE Mark Certification for Machine Vision Image Guided Spine Surgery

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July 15, 2020

7D Surgical announced today that it has achieved CE Mark certification for its innovative Machine-vision Image Guided Surgery (MvIGS) system for spine surgery. This achievement clears the way for 7D Surgical to commence commercialization efforts of its spinal platform across the European market and additional global regions.

7D Surgical MvIGS System is the only approved image guidance system that utilizes a novel and proprietary camera-based technology, coupled with machine-vision algorithms to eliminate the long-standing frustrations with legacy surgical navigational platforms. The speed, accuracy, and efficiency of the MvIGS System, combined with a fundamentally streamlined surgical workflow provide significant economic value and harnesses the true potential of image guidance – all while enabling a safe, radiation-free surgical environment.

“We are extremely excited to achieve our CE Mark. With successful launches already underway in the United States, Canada, Australia, New Zealand and the Caribbean, we are eager to begin expanding the MvIGS technology into the European spine market,” said Beau Standish, Chief Executive Officer of 7D Surgical. “We are very proud of our team for accomplishing this important milestone and we are continuing our growth and expansion into international markets.”

Through 7D Surgical’s proprietary Flash™ Registration and Flash™ Fix technology, the platform is the only spine navigation system to offer true segmental registration. It utilizes visible light to not only allow spine surgeons to perform spinal registration in just seconds, but it also allows each vertebral body to be registered independently. As a result, system accuracy is not dependent on the position of the patient’s spine or patient movement that may occur over the course of the procedure. In addition, Flash™ Registration saves valuable operative time and eliminates intraoperative radiation exposure to the surgeon, staff, and patient.

“Accomplishing true segmental registration with our Flash™ Technology has had a tremendous impact on the safety and efficacy of the system, as it results in high navigational accuracy in mobile areas of the spine and complex anatomy,” said Brian Stuart, Chief Revenue Officer for 7D Surgical. “We are truly transforming what medical imaging and navigation is and what it can do to improve patient outcomes, while driving down healthcare costs.  We are extremely excited to introduce our novel 7D MvIGS system to European customers later this year.”

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