The Toronto, Canada-based 7D Surgical, Inc. recently announced two major milestones in its progress into the Asian Market. The company received Health Sciences Authority (HSA) approval in Singapore for its Machine-vision Image Guidance System (MvIGS) for navigating spinal surgeries.
7D Surgical Achieves Key Milestones in Asia
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The accomplishment complements the company’s U.S. FDA 510(k) clearance, CE certification, and Health Canada approval. The company also announced its first sale of the MvIGS through its Southeast Asia distribution partner, Transmedic.
7D Surgical CEO Beau Standish described his excitement in a press release from the company: “We are incredibly thrilled to bring our 7D technology to market in Singapore. We have already delivered this novel technology to the USA, Canada, Australia, New Zealand, and the Caribbean and are now excited to offer our innovations in the Asian market. Our machine vision surgical innovations improve patient outcomes by reducing surgical risk, improve implant accuracy, increase surgical efficiencies, while eliminating navigation-based intraoperative radiation. Expansion into Asia has been a strategic priority to share our innovations with the global healthcare community.”
Instead of infrared imaging common with other navigation systems, the 7D system uses cameras and machine vision to recognize landmarks and instruments. Kevin Lim, Chairman of the Division of Surgery and Senior Consultant Orthopedic Surgeon at KK Women’s and Children’s Hospital in Singapore, who has worked with the system, said, “As a pediatric spine surgeon, the 7D system allows me to safely and accurately navigate pedicle screws at any level for any type of case, without disruption to my workflow. It is particularly paramount in some of my more complex cases, and I am proud to be able to offer my patients the very latest in spine surgery while eliminating unnecessary radiation in the operating room.”
Another benefit of the camera-based technology is the segmentation of the preoperative imaging, so that additional imaging is not necessary after making corrective adjustments to the spine. “We are very pleased to be partnered with 7D Surgical and representing the technology in Singapore and eventually all of Southeast Asia,” said Teo Kee Meng, Managing Director at Transmedic.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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