7D Surgical

60 Scarsdale Road, Unit 118, Toronto, Ontario M3B 2R7, Canada All Canada companies → — Founded 2009

Medical Device / Hardware Specialty-Focused AI

Neurosurgery

Neurology AI Surgical AI

Acquired

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Products

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

7D Surgical

Neurology AI

The 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application is a radiation-free, AI-powered machine-vision image-guided surgery (MvIGS) platform for precise and rapid neurosurgical navigation in cranial procedures.

Approximately $470,000 usd

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About 7D Surgical

7D Surgical, now an operating subsidiary of SeaSpine Holdings Corporation, specializes in advanced image-guided surgery systems that leverage proprietary machine vision technology. Their flagship product, the FLASH™ Navigation System, is designed to significantly enhance surgical workflows and patient care in spine and cranial procedures. For physicians, this system offers a radiation-free alternative to traditional intraoperative imaging methods like CT and fluoroscopy, which typically expose both patients and surgical staff to ionizing radiation.

The FLASH™ Navigation System utilizes sophisticated camera-based technology and machine vision algorithms to create real-time, high-definition 3D images of the surgical anatomy in mere seconds. This rapid registration process, often completed in under 30 seconds, dramatically reduces operative time compared to the 30 minutes typical with older systems. The system provides precise guidance for instrument placement, akin to a GPS for surgery, improving accuracy and patient safety, particularly in complex procedures such as spinal fusion or screw placement. Its application extends to both spine and cranial surgeries, with potential for future advancements in other surgical specialties.

7D Surgical was acquired by SeaSpine Holdings Corporation in May 2021 for an estimated $110 million to $121 million in cash and stock, integrating its innovative technology into SeaSpine’s comprehensive portfolio of surgical solutions for spinal disorders.

What Physicians Need to Know

Specialization

7D Surgical, now part of Orthofix (formerly SeaSpine), specializes in Machine-vision Image Guided Surgery (MvIGS) for spine and cranial procedures. They develop advanced optical technologies and machine vision-based registration algorithms to enhance surgical workflow and patient care.

Key Differentiators

Their flagship product, the FLASHu2122 Navigation System, is the first and only platform to offer radiation-free surgical navigation, eliminating intraoperative X-rays or fluoroscopy. It boasts an incredibly fast workflow with 'Flash Registration' in under 20-30 seconds, using only visible light. The system's machine-vision technology, similar to that in self-driving cars, is embedded in an overhead surgical light, resolving traditional line-of-sight issues and offering sterile, foot-pedal control to the surgeon. It also features segmental registration, maintaining accuracy even with patient or intraoperative movement.

Technology Stack

The core technology is Machine-vision Image Guided Surgery (MvIGS), utilizing structured light imaging, which combines a light projector with two stereoscopic video cameras. It employs advanced optical technologies and proprietary machine vision algorithms to acquire precise 3D images of the exposed anatomy in seconds. These live 3D images are then digitally merged and co-registered with pre-operative CT scans. The 7D MRVisionu2122 offering further extends this by generating synthetic CTs from MRI scans for planning and navigation, completely eliminating radiation from the entire workflow.

Physician Tip

For physicians, the 7D Surgical FLASH Navigation System offers significant advantages: enhanced patient and staff safety by eliminating intraoperative radiation exposure; unmatched precision and accuracy for implant placement through highly detailed 3D imaging and continuous guidance; and a dramatically faster surgical workflow, reducing operative time and time under anesthesia. The integrated system design, with tracking components in an overhead light and foot pedal control, improves ergonomics and gives surgeons complete sterile control, minimizing line-of-sight frustrations. This leads to improved patient outcomes, including potentially faster recovery times. The system is versatile, applicable for various posterior spinal procedures and cranial navigation.

The 7D Surgical FLASH Navigation System is designed for seamless integration into existing operating room workflows, being compact and agile. It utilizes pre-operative CT data, which can be imported via CD-ROM, USB, or PACS. With 7D MRVisionu2122, it can also integrate synthetic CTs generated from MRI scans. The system is agnostic, allowing for the use of interchangeable surgical tools that are tracked by its cameras. It supports both traditional open surgical techniques and minimally invasive approaches.

At a glance

Founded 2009

HQ 60 Scarsdale Road, Unit 118, Toronto, Ontario M3B 2R7, Canada · Canada

Team size 52

CEO Beau Standish

Funding Acquired

Products 1

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Products by 7D Surgical

1 product in the directory

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

7D Surgical

Neurology AI

Approximately $470,000 usd

What the Web Says

7D Surgical, now part of SeaSpine, has developed a machine-vision image-guided surgery (MIGS) system for spine and cranial procedures. The system is generally well-received by healthcare professionals for its innovative technology that aims to improve surgical precision, reduce radiation exposure, and decrease operating and recovery times. While specific product reviews from platforms like G2, Capterra, and Reddit are limited, the available information from healthcare IT reviews and medical articles highlights the system's benefits. Employer reviews, primarily from Indeed, suggest a positive work environment with smart and hardworking individuals.

Overall: Positive

Strengths

Radiation-free procedures, eliminating intraoperative X-rays or CT scans.
Increased precision and accuracy in spinal implant placement.
Faster surgical workflow and reduced operating times.
Decreased recovery times for patients.
Real-time, seamless 3D visualization of patient anatomy.
Cost-effective compared to traditional imaging systems (around $450,000, less than half the price).

Limitations

Limited public product reviews on major platforms like G2, Capterra, and Reddit.
Specific employer reviews are scarce, making it difficult to form a comprehensive understanding of company culture beyond general positive statements.
Some Reddit discussions about spine surgery, while not directly about 7D Surgical, indicate a general patient concern about finding good surgeons and the potential for complications or dissatisfaction with outcomes, which could indirectly relate to any surgical technology.
No specific negative feedback regarding the product or company was found in the provided search results.

Based on reviews from: Indeed.com, Lehigh Valley Health Network, PMC (PubMed Central), AuntMinnie.com, CT Orthopaedic Institute | St. Vincent's Medical Center, Dallas Innovates, Becker's Spine Review, Hoag Hospital, Hartford HealthCare, YouTube

Last updated: 2026-07-17

Videos

News, demos, and interviews about 7D Surgical.

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Press & Coverage

PR Newswire

7D Surgical Receives FDA 510(K) and Health Canada MDL Clearance for Its Breakthrough Image Guidance System for Spine Surgery

7D Surgical announced it received 510(k) clearance from the U.S. FDA and a medical device license from Health Canada for its Machine-vision Image Guided Surgery (MIGS) system for spine surgery. This system uses 3D optical technologies and machine vision algorithms to provide a faster, radiation-free alternative to existing image-guided surgery options.

2017-01

PR Newswire

7D Surgical Completes Significant Round of Financing

7D Surgical completed its largest round of financing to date, providing capital to support the commercial launch of its FDA 510(k) approved Machine-vision Image Guided Surgery (MvIGS) system and develop new features for spine and cranial surgical navigation.

2018-02

Ortho Spine News

SeaSpine Announces FDA 510(k) Clearance of 7D Surgical Percutaneous Spine Module for Minimally Invasive Surgery

SeaSpine Holdings Corporation announced FDA 510(k) clearance of its 7D Percutaneous Spine Module for minimally invasive surgery, a new application for its 7D Flashu2122 Navigation System. This follows SeaSpine's acquisition of 7D Surgical and aims to address an important part of the spine navigation market.

2021-07

Ortho Consulting Group

SeaSpine Announces Closing of 7D Surgical Acquisition

SeaSpine Holdings Corporation announced the closing of its acquisition of 7D Surgical, a Toronto-based company developing advanced optical technologies and machine vision-based registration algorithms for surgical navigation. The acquisition, valued at $110 million, aims to expand SeaSpine's offerings in spine and cranial surgeries.

2021-05

Frontiers in Surgery / PMC - NIH

Machine Vision Navigation in Spine Surgery

This peer-reviewed article discusses the 7D Surgical System as the first machine vision navigation system for spine surgery, highlighting its ability to improve intraoperative workflow and efficiency by providing accurate screw insertion without intraoperative imaging or radiation exposure.

2021-03

AdventHealth

AdventHealth for Children One of First in Country to Use 7-D Surgical Navigation System to Enhance Pediatric Spine Surgery Safety

AdventHealth for Children became the first children's hospital in Florida and the eastern U.S. to use the 7D Surgical FLASHu2122 Navigation System, offering a quicker, radiation-free alternative for pediatric spinal surgery. The system uses machine vision technology to create a 3D image map for precise surgical guidance.

2022-03

Business Wire

Orthofix Announces First Cases and Full Commercial Launch of the 7D FLASH Navigation System Percutaneous Module 2.0 for Minimally Invasive Surgery

Orthofix Medical Inc. announced the full commercial launch and successful completion of the first U.S. cases with the 7D FLASHu2122 Navigation System Percutaneous Module 2.0. This module expands the clinical functionality of the system for minimally invasive spine surgery.

2023-08

Norton Children's Hospital

New orthopedic surgery tool reduces kids' X-ray exposure while increasing precision

Norton Children's Hospital introduced the 7D Surgical Navigation System, becoming the first pediatric hospital in Kentucky to use this technology. It enhances scoliosis treatment by providing advanced imaging and reducing radiation exposure for pediatric patients.

2024-08

Frequently Asked Questions

What are 7D Surgical's primary AI-powered products and their core benefits for surgical procedures?

7D Surgical's flagship product is the 7D FLASH Navigation System, which uses machine-vision AI and 3D optical technologies for image-guided surgery in spine and cranial procedures. Its core benefits include radiation-free patient registration in seconds, improved surgical workflow, and enhanced precision, aiming to increase patient safety and operating room efficiency.

How does 7D Surgical ensure regulatory compliance and patient data privacy, especially concerning its AI components?

The 7D FLASH Navigation System has received FDA 510(k) clearance and Health Canada MDL approval for its spine and cranial applications, demonstrating regulatory compliance for its medical device functionality. As a medical device company handling patient anatomical data, 7D Surgical is expected to adhere to stringent data privacy and security standards, including those outlined by HIPAA, for the handling of protected health information.

What is the typical pricing model for 7D Surgical's systems, and how does it compare to traditional image-guided surgery solutions?

The 7D Surgical system reportedly costs around $450,000, which is significantly less than many traditional imaging systems that can exceed $1 million. The company also offers the 7D MRVisionu2122 as an annual subscription, and its radiation-free approach can reduce setup costs by eliminating the need for additional 3D or CT imaging equipment.

What kind of training and ongoing support does 7D Surgical provide to healthcare facilities and surgical teams?

7D Surgical offers comprehensive customer training, including on-site instruction from Clinical Solutions Specialists, to ensure surgical teams can effectively utilize their systems. They also provide direct customer support via email and phone for ongoing assistance and technical inquiries.

What are 7D Surgical's key partnerships, and how do they impact product integration and market reach?

7D Surgical was acquired by SeaSpine Holdings Corporation in 2021, integrating its technology into SeaSpine's broader portfolio and expanding its market reach. They also have strategic distribution agreements with companies like LifeHealthcare Group and Spartan Medical, and a partnership with MRIguidance for radiation-free pre-operative imaging using BoneMRI software.

Given the rapid evolution of healthcare AI, what is the long-term stability and vision for 7D Surgical?

7D Surgical's acquisition by SeaSpine Holdings Corporation in 2021 provides significant stability and integration into a larger, established medical technology company. This merger aims to combine innovative cultures to expand clinical value and accelerate market share, leveraging 7D Surgical's advanced navigation platform within a comprehensive spinal implant and orthobiologics portfolio.

How does 7D Surgical address concerns about data security and patient privacy with its AI-driven image guidance systems?

While specific protocols for 7D Surgical's AI are not explicitly detailed, as a medical device company, it operates under strict regulatory frameworks like FDA clearance which implicitly require robust data security. The system processes patient anatomical data and integrates with pre-operative scans, necessitating adherence to HIPAA regulations for protected health information through secure data handling, access controls, and audit trails.

How does 7D Surgical ensure the accuracy and reliability of its machine-vision AI for surgical navigation?

The 7D FLASH Navigation System utilizes proprietary machine-vision algorithms and 3D optical technologies to achieve highly accurate and reliable surgical guidance. Its FDA 510(k) clearances and clinical evaluations, including trials at Sunnybrook Health Sciences Centre, validate the system's performance in providing precise anatomical registration and tool guidance for spine and cranial procedures.

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