FLASH™ Navigation System with 7D Technology — Surgical navigation through machine vision (spine and cranial)

FLASH™ Navigation System with 7D Technology is a machine-vision-based surgical navigation platform, originally developed by 7D Surgical Inc. (Toronto, Canada) — a company founded from biophotonics and biomedical engineering research by a team at Sunnybrook Health Sciences Centre and the University of Toronto. The technology was acquired by SeaSpine in 2021, and following the 2023 SeaSpine–Orthofix merger it is now marketed under the Orthofix brand. In Romania, the system is available through the Curexo area of the Ronda Medical portfolio.

Unlike navigation systems based on fluoroscopy or intraoperative computed tomography (CT), FLASH™ uses exclusively visible light for registration: a surgical light head integrates machine-vision cameras and a FLASH™ projection system, which optically digitizes the exposed anatomical surface — over 250,000 reference points, according to the pivotal clinical study that validated the technology — and automatically registers it, through point-to-point matching, to the preoperative imaging (CT and/or MRI). The complete registration process takes about 20 seconds; if re-registration is needed during the procedure (for example after patient repositioning), the FLASH™ Fix function performs it in under 10 seconds, without additional radiation and without repeating the point-matching step.

The platform includes three software modules: Spine (open approach, with segmental registration per vertebral level and preoperative CT imaging, with no intraoperative radiation), MIS (minimally invasive surgery, with intraoperatively acquired CT imaging), and Cranial (cranial procedures, with preoperative CT and/or MRI imaging, registrable to any cranial region with a rigid anatomical reference, including the posterior fossa). The system is "implant neutral" — compatible, through proprietary integration adapters, with instrumentation and fixation systems from any manufacturer — and is fully controlled by the surgeon from the sterile field, via a foot pedal and a sterile light handle mounted directly on the light head. The platform's accuracy and workflow efficiency are documented by a clinical research program published in peer-reviewed journals, including a prospective randomized study, large clinical series, and a dedicated evaluation in complex pediatric spinal deformities (see the clinical evidence below).

• Posterior spinal fixation procedures, open approach — guided pedicle screw placement, at any level where a rigid anatomical reference can be identified (Spine module, preoperative CT imaging, no intraoperative radiation).
• Minimally invasive spinal procedures (MIS) — navigation with intraoperatively acquired CT imaging (MIS module).
• Image-guided cranial procedures — localization of intracranial lesions, craniotomy planning, placement of cranial fixation plates and screws (Cranial module, preoperative CT and/or MRI imaging).
• Complex spinal deformities, including in pediatric patients — extensive surgical exposures, distinctive anatomy, and increased spinal mobility, with the option of segmental registration per level.

A selection of publications and studies that mention use of the system. Summaries are indicative; for details, consult the original source.