Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

7D Surgical Receives Clearances For Its Breakthrough Image Guidance System For Spine Surgery

January 24, 2017 By 7D Surgical

7D Surgical announced that it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a medical device license from Health Canada enabling the North American commercial launch of its innovative Machine-vision Image Guided Surgery (MIGS) system for spine surgery, the 7D Surgical System. 

The 7D Surgical System employs cutting-edge 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. This new technology can easily register spinal surgery patients automatically using only visible light. Unlike time-consuming conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new platform can achieve an incredibly fast surgical workflow for spine procedures.

“When navigating the spine, surgeons traditionally have had two time-consuming and expensive IGS options: systems that rely on intraoperative radiation emitting devices or systems that utilize laborious manual point matching techniques,” says Beau Standish, Chief Executive Officer of 7D Surgical. “We believe the inefficiencies of these systems have limited the adoption of IGS in spine procedures to less than 20 percent. 7D Surgical’s MIGS system has now removed these barriers, providing surgeons and their hospitals with a superior product option.”

(Image credit: 7D Surgical)

The 7D Surgical System enables near-instantaneous Flash Registration of the patient’s anatomy. “Guided by our product philosophy of ‘surgeons designing for surgeons,’ we have achieved an unprecedented entire workflow time of less than 20 seconds for de novo spinal registration, unheard of in the spinal IGS world where such registration can interrupt surgery for up to 30 minutes,” says Dr. Victor Yang, president and chief scientific officer of 7D Surgical, senior scientist at Sunnybrook Research Institute, and staff neurosurgeon at Sunnybrook Health Sciences Centre in Toronto, where prototype MIGS technology has been used in more than 160 patients in clinical trials.

The MIGS navigation technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the operating room, and is manifested in simplified yet powerful software, which is controlled by the surgeon using only a foot pedal. “Our surgeons don’t rely on non-sterile personnel to operate the technology. Our surgeons are in total control,” says Yang.

“Image guided surgery technology has finally caught up to the needs of a practicing spine surgeon,” says Dr. Frank Cammisa, chief mmeritus of the Spine Service at Hospital for Special Surgery in New York City. “7D Surgical’s new MIGS system appears to provide a faster, radiation-free alternative to existing options. It could be an important new tool in expanding the use of IGS in spine procedures. The 7D Surgical System reduces the overall cost and footprint required to navigate the spine. It’s a win-win for the surgeon and the hospital.”

With both U.S. and Canadian regulatory authorization, 7D Surgical has commenced execution of its North American commercialization strategy. “We are delighted to have achieved these regulatory milestones in line with our expectations and planning,” says Standish. “We are confident that in demonstrating the speed and efficiency of our MIGS system, we will convince more surgeons to employ IGS in their spine procedures.”

Related Articles Read More >

Lazurite ArthroFree wireless surgical camera system Minnetronix Medical
How Minnetronix Medical helped Lazurite with its wireless surgical camera
Medtronic Hugo robot-assisted surgery system
The road to a robot: Medtronic’s development process for its Hugo RAS system
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A portrait of Stryker executive Tracy Robertson
Stryker leaders talk medtech trends at DeviceTalks Boston: ‘If you’re slow, you’re going to lose’

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech