Zeta Surgical's Mixed Reality Navigation System Receives FDA Clearance
NEWS: ZETA RECEIVES FDA CLEARANCE
Zeta Surgical's Mixed Reality Navigation System Receives FDA Clearance
Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S. Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system.
BOSTON (USA), Sept. 11, 2023 — The Zeta Cranial Navigation System is a mixed-reality navigation system for neurosurgery that provides surgeons with "GPS-like" guidance with millimetric accuracy in real time. Zeta's computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. Zeta can be deployed both inside and outside the operating room, eliminating the need for general anaesthesia and rigid skull immobilisation.
Dr. William Gormley, Chief Medical Officer of Zeta Surgical and Harvard Medical School Associate Professor, commented on the clearance: "The FDA's market clearance of the Zeta Navigation system ushers in the next generation of innovation to neurosurgery. Like all paradigm changing innovations, Zeta will change the way we conceive of where we can perform neurosurgery within our hospitals and where in the world these hospitals can be."
"Zeta Surgical has created a platform technology that not only improves existing techniques and workflows but also enables novel therapies, expanding the scope of treatment for neurologic diseases," said Dr. Kyle Wu, Director of Neurosurgical Innovation at The Ohio State University Wexner Medical Center.
"Not only can the Zeta platform be used to navigate the most complex cranial surgeries, but it can also enable more routine cranial surgeries to be done in lower cost settings outside of a traditional OR without the need for general anaesthesia," said Dr. Matthew McGirt, Professor of Neurosurgery at Atrium Health-Wake Forest, and a Director at the Carolina Neurosurgery & Spine Associates. "Few technologies improve both quality and cost for hospital systems like Zeta does."
Zeta Surgical CEO, Jose Amich, highlighted the contributions of the Design + Industry team in the successful commercialisation of the technology, commenting “D+I has been an indispensable development partner, playing a pivotal role in our journey from prototype to FDA clearance. Besides being safe and effective, The Zeta Cranial Navigation System is beautifully designed and remarkably user-friendly. Their exceptional design capabilities, ISO compliance knowledge, and unparalleled speed and effectiveness make them truly outstanding in the industry."
"Securing FDA clearance is a significant milestone for Zeta Surgical, and we are proud to have contributed to their success," said Paul Scopes, Development Manager at D+I. "This project showcases our ability to manage different interdependencies across the entire development process, ensuring we deliver safe and compliant medical technologies to providers and patients globally. The Zeta team's pragmatism and innovation have been instrumental in bringing their vision to market. This achievement is a testament to their dedication and determination to empower surgeons with cutting-edge technologies."
Zeta Surgical, which has been working on this technology for almost a decade, was established by CEO Jose Amich who earned his undergraduate degree in molecular biology from Harvard in 2018 and co-founded the company the same year with his classmate Raahil Sha, who serves as chief technology officer. Zeta Surgical has received funding from investors including Innospark Ventures and Y Combinator, as well as forging partnerships with Massachusetts General Hospital, Brigham and Women's Hospital, Singapore's National Neuroscience Institute and Singapore General Hospital.
FDA 510(k) clearance enables Zeta to simplify the workflow, expand the use environment, and reduce the need for anaesthesia, making clinically established technology more accessible. These advancements have the potential to transform how neurosurgery is performed, offering improved outcomes for patients.
To learn more, visit zetasurgical.com and design-industry.com.au/zeta-surgical
Jose Amich (Zeta Surgical): jose.amich@zetasurgical.com
Design + Industry: info@design-industry.com.au
D+I brings together a rare and perfect blend of deep technical/vertical expertise and beautiful, highly usable design. Their firm is by far the most exciting and talented firm in the medtech space globally. It is the go-to firm for top startups funded by investors such as Y Combinator and Founders Fund, and have extensive experience working with large players such as Siemens and others. D+I helped us develop our surgical guidance system, and have been an integral part of our journey and an absolute pleasure to work with.
— Jose Amich, CEO @ Zeta Surgical
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About Zeta Surgical
Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures. Its navigation and robotics platform leverages cutting-edge computer vision and artificial intelligence to enable surgical guidance directly at the point-of-care, democratizing care by creating new possibilities in fields such as emergency care, interventional medicine, and drug delivery. Zeta Surgical was founded by Harvard graduates and faculty and is backed by leading investors.
A new frontier in surgical guidance:
Transforming surgery with mixed reality and collaborative robotics
About Design + Industry
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NEWS PROVIDED BY: ZETA SURGICAL
Zeta's navigation and robotics platform leverages cutting-edge computer vision and artificial intelligence to enable surgeons to operate at the point-of-care.