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PathKeeper Surgical Receives FDA 510k Clearance for Spine Navigation System

PathKeeper improves clinical experience and reduces the reliance on radiation in spine surgery


Kfar Saba, Israel, June 8, 2023 – PathKeeper Surgical, a privately-held, Israel-based, medical technology company, dedicated to improving the health of individuals around the world suffering from all spinal issues requiring surgery, while making navigation-guided surgery available to any patient in all operating rooms, received its U.S. Federal & Drug Administration (FDA) 510(k) clearance for its Path

PathKeeper System

Keeper, 3D optical navigation system.


“We are excited to reach this important milestone for PathKeeper and the company,” expressed Erez Lampert, Chief Executive Officer and Founder. “We now move our focus to commercialization in the United States to make PathKeeper available to all spine surgeons and their patients.”


The PathKeeper system was designed to replace traditional navigation technology with a 3D optical navigation system that offers active, real-time, independent tracking of patient anatomy and surgical instruments, accuracy of implantation to less than a millimeter, more efficient surgical workflow, elimination of radiation exposure during the surgical procedure and a more economical price so both hospital and ambulatory-surgical center operating rooms can incorporate this new technology.


“There is a definite need for a new navigation system that is adaptable and easily integrated into operating rooms. PathKeeper took that challenge and created a spine navigation system that is easily operated, offers real-time tracking and eliminates radiation exposure during the procedure. This is the new standard of care,” explained Tushar Patel, MD, Washington Orthopaedics & Sports Medicine, Chevy Chase, MD.


PathKeeper Surgical received its FDA 510k clearance earlier this year for the PathKeeper system. The name PathKeeper effectively describes the essence of the system - a 3D optical navigation system that 'keeps' the surgical 'path' on course throughout the surgery.


About PathKeeper Surgical

PathKeeper Surgical is an Israeli-based, medical technology company that has established a solution to combat the high failure rates seen in spinal surgeries. PathKeeper was founded in 2018 by Erez Lampert, a top 3D medical imaging expert with more than 20 years of experience in the healthcare and aerospace industries, and a proven track record in the field of 3D imaging. Erez previously served as the R&D leader for the Itero Element Intraoral Scanner for Align Technology (Invisalign), the leading 3D dental scanner in the world today. Josh Schroeder, MD, the Director of Spinal Deformities at Hadassah Medical Center and a HSS fellow, has been onboard since the inception of the company as a clinical advisor. Erez and Josh’s combined knowledge enabled the company to develop an innovative navigation system that outperforms existing solutions. Learn more at path-keeper.com.


U.S. Media Contact:

Ryan LeBlanc

Chief Commercial Officer

ryan.leblanc@path-keeper.com

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