7D Surgical Gains CE Mark for Spinal Image Guidance System

By Julie A. Vetalice

7D Surgical Gains CE Mark for Spinal Image Guidance System

7D Surgical achieved CE Mark approval for its Machine-vision Image Guided Surgery (MvIGS) system for spine surgery. Launch in Europe is slated for later this year.

MvIGS is the only approved image guidance system that uses a novel, proprietary camera-based technology, coupled with machine-vision algorithms. The system uses pre-op CT or MRI images (not x-ray or intra-op CT), then employs 3D patient digitization to provide surgical guidance accuracy. Patients can be quickly and automatically registered using only visible light and 7D Surgical's Flash Registration technology. Each vertebral body is registered independently.

"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."

Product Labels: Surgical Navigation

Tags: CE Mark, Regulatory