Products

FLASH EVD System (10-0002)
7D Surgical ULC
Neurology AI
The FLASH EVD System by 7D Surgical ULC is an AI-powered, radiation-free surgical navigation platform for precise, bedside placement of external ventricular drains (EVDs) using advanced machine-vision technology.

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About 7D Surgical ULC

7D Surgical ULC, now part of Orthofix (previously SeaSpine), is a pioneering medical technology company that developed the Machine-vision Image Guided Surgery (MvIGS) platform, known as the 7D Surgical System. This innovative system is designed to significantly enhance surgical workflow and patient care, particularly in spine and cranial procedures. Unlike traditional image-guided surgery (IGS) systems that often rely on intraoperative radiation (such as X-rays or CT scans) and can be time-consuming, the 7D Surgical System utilizes advanced 3D optical technologies and machine vision algorithms to provide radiation-free navigation.

For physicians, the key benefits include near-instantaneous patient registration, often in less than 20-30 seconds, using only visible light (Flash Registration™ technology). This dramatically reduces operative time and eliminates radiation exposure for the surgeon, staff, and patient. The system’s technology is akin to that found in self-driving automobiles, offering highly precise, real-time 3D anatomical visualization and tool guidance. It supports both open and minimally invasive surgical approaches, aiming to improve accuracy, efficiency, and safety in complex spinal and cranial procedures.

Focus Areas

Image-guided surgery machine vision spine surgery cranial surgery radiation-free navigation surgical workflow improvement minimally invasive surgery

Business Intelligence

PartnershipsLifeHealthcare Group Limited (Australia and New Zealand), Surgical One, DB Surgical, OrthoPediatrics (for pediatric applications)
AcquisitionsAcquired by SeaSpine Holdings Corporation (now Orthofix) in 2021 for $110 million
TechnologyMachine-Vision Image Guided Surgery (MvIGS) platform, visible light navigation, Flash Registration™ technology, 3D optical technologies, machine vision algorithms, AI operating system
FDA Clearances3 cleared products (estimated)

Products by 7D Surgical ULC

1 product in the directory

FLASH EVD System (10-0002)
7D Surgical ULC
Neurology AI
The FLASH EVD System by 7D Surgical ULC is an AI-powered, radiation-free surgical navigation platform for precise, bedside placement of external ventricular drains (EVDs) using advanced machine-vision technology.

What the Web Says

7D Surgical ULC is a Toronto-based medical device company specializing in advanced optical technologies and machine vision-based registration algorithms for surgical navigation, particularly in spine and cranial surgeries. Their flagship product, the 7D Surgical System (also known as 7D FLASH Navigation System), aims to improve surgical workflow and patient care by offering a faster, radiation-free alternative to existing image-guided surgery (IGS) systems. The system has received FDA 510(k) clearance and Health Canada approval for spinal applications.

Overall: Positive

Strengths

  • Faster surgical workflow and registration time (under 20-30 seconds) compared to traditional IGS systems.
  • Radiation-free imaging, eliminating the need for intraoperative X-ray, CT scans, or fluoroscopy.
  • Enhanced safety and precision in screw placement, particularly in complex spinal surgeries.
  • Reduces overall cost and footprint required for navigation.
  • Eliminates line-of-sight frustrations with an overhead tracking camera system.
  • Offers real-time feedback on optimal screw length and trajectory.

Limitations

  • Some reported adverse events, including probe slips and initial screw skiving, though often not attributed to device malfunction.
  • Potential for neurological motor loss in rare cases, though patient recovery is anticipated.
  • One instance where a surgeon switched to an alternative navigation system due to an issue, causing a delay.
  • Limited public reviews available on major platforms like G2, Glassdoor, and Capterra specifically for 7D Surgical ULC as a product or employer.
  • Some employer reviews for similarly named companies (7 D Wholesale, 7D Industries) indicate concerns about work-life balance, pay, management, and training, but these may not be directly applicable to 7D Surgical ULC.

Based on reviews from: Indeed.com, accessdata.fda.gov, PR Newswire, NeuroSpine, 24X7mag, YouTube, PMC, Reddit

Last updated: 2026-07-17

Videos

News, demos, and interviews about 7D Surgical ULC.

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Press & Coverage

Ortho Consulting Group
SeaSpine Announces Closing of 7D Surgical Acquisition
SeaSpine Holdings Corporation announced the closing of its acquisition of 7D Surgical, integrating 7D Surgical's machine-vision, image-guided surgery platform with SeaSpine's orthobiologics and spinal implant solutions. This acquisition aims to accelerate innovation and expand their reach in surgical solutions.
2026-05
accessdata.fda.gov
MAUDE Adverse Event Report: 7D SURGICAL ULC 7D SURGICAL SYSTEM; NAVIGATION SYSTEM
An adverse event report details a probe slip during pedicle prep using the 7D Surgical System, resulting in neurological motor loss, though the event was not definitively linked to device malfunction. The patient is reportedly recovering well with rehab.
2026-04
unknown
Integration of Machine Vision Technology in the Treatment of Pediatric Spinal Deformities
This study describes the use of the 7D FLASH Surgical System for complex pediatric spinal surgery, highlighting its machine vision navigation technology that registers bony anatomy with a preoperative CT scan. The system aims to improve intraoperative workflow and efficiency.
2025-06
Tracxn
7D Surgical - 2025 Company Profile, Team, Funding & Competitors - Tracxn
7D Surgical, an acquired company, has raised a total funding of $581K over three rounds, with its first funding round in February 2018. The company, founded in 2009, is a provider of image guidance systems for spine surgery.
2025-08
unknown
7D Surgical System Brings Advanced Technology Close to Home
Lehigh Valley Hospitalu2013Dickson City is the first in its region and state to offer the 7D Surgical System, providing radiation-free image-guided surgery for spinal and cranial navigation. The system uses sophisticated camera-based technology, similar to that in self-driving cars, to quickly take detailed images and calibrate them for precise instrument placement.
2022-05
accessdata.fda.gov
May 20, 2022 7D Surgical Daniel Ziskind Director, Quality & Regulatory 60 scarsdale road, unit 118 Toronto, Ontario M3B 2R7 - accessdata.fda.gov
The FDA issued a 510(k) clearance for the 7D Surgical System - Percutaneous Application (7D Flash Frame), indicating its substantial equivalence to predicate devices for minimally invasive image-guided spine surgery. The system is intended for spatial positioning and orientation of spinal surgical instruments.
2022-05
PMC
Visible Light Navigation in Spine Surgery: My Experience With My First 150 Cases - PMC
This article reviews the author's experience with visible light navigation using the 7D Surgical System, highlighting its use of structured light imaging and machine vision algorithms for precise 3D imaging and registration in spine and cranial surgery. The system offers real-time multiplanar images and augmented reality features.
2022-05
Ortho Spine News
SeaSpine Announces FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery
SeaSpine announced FDA 510(k) clearance for the 7D Surgical Percutaneous Spine Module, designed for minimally invasive surgery. This expands the capabilities of the 7D Surgical System for less invasive spinal procedures.
2021-07
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