Zeta Surgical

Zeta Surgical is a privately held American medical-technology company headquartered in Boston, Massachusetts. Founded in 2018 by Harvard graduates Jose Amich and Raahil Sha together with neurosurgeon William Gormley of Brigham and Women's Hospital, the company focuses on computer-assisted surgical navigation for cranial procedures, neurosurgery, and related image-guided interventions. Its central product and technology platform, ZETA, is designed to provide a GPS-like layer of spatial guidance during surgery by combining computer vision, artificial-intelligence algorithms, image registration, and patient tracking. A defining aspect of Zeta Surgical's approach is the use of real-time computer vision and parallel computing to register images and track a patient without relying on rigid head fixation. The company has reported preclinical and clinical evaluation of the system in applications including neurotrauma, intracerebral hemorrhage, brain biopsy, and navigated transcranial magnetic stimulation. The stated objective is to support submillimeter accuracy while giving clinical teams a more flexible navigation workflow than conventional systems that depend heavily on fixed frames or markers. ZETA received its first United States Food and Drug Administration 510(k) clearance for cranial surgical procedures in September 2023. Additional clearances in 2024 expanded the system's indications and compatible instruments. The company also received FDA clearance for the Zeta TMS Navigation System, supporting navigated transcranial magnetic stimulation procedures. These regulatory milestones moved Zeta Surgical's platform from development and clinical evaluation toward use in regulated clinical settings. Beyond its core cranial-navigation product, Zeta Surgical has explored applications in interventional neuroradiology and focused ultrasound. In 2022, it announced work on a focused-ultrasound system for intracranial drug delivery navigated by ZETA. The company is also a member of the Focused Ultrasound Foundation, reflecting its interest in noninvasive and image-guided neurological therapies. In 2024, it reported completion of its first multicenter trial at Singapore General Hospital and Tan Tock Seng Hospital in Singapore. The company has received design recognition, including an iF Design Award and a Good Design Award in 2023, and has worked with Australian product-design and consultancy firm Design + Industry. Its reported investors include Y Combinator, Artesian Hostplus VC, Innospark Ventures, Trevor Fetter, Gabriel Hammond, and Marc de Garidel. Zeta Surgical has also identified advisors including Elad Levy and George Bickerstaff, the latter described as a former chief financial officer of Novartis Pharma AG. The company remains privately held, and publicly available reference material does not establish a broader corporate parent, public listing, or current executive roster beyond its founding team.

Zeta Surgical was established in 2018 by Jose Amich and Raahil Sha, who began developing the company while studying at Harvard University, together with William Gormley, a Harvard Medical School professor and neurosurgeon at Brigham and Women's Hospital. Amich and Gormley are also alumni of the MIT Sloan School of Management MBA program. The founding group combined software and entrepreneurial experience with clinical neurosurgical expertise, forming the basis for a company focused on computer-assisted surgical navigation. The company's technology was developed around the premise that neurosurgical navigation could use real-time computer vision and artificial intelligence rather than depending exclusively on rigid head fixation. Zeta Surgical's system uses parallel computing for image registration and patient tracking. Preclinical and clinical work evaluated whether this approach could maintain submillimeter accuracy in procedures and research settings including neurotrauma, intracerebral hemorrhage, brain biopsy, and transcranial magnetic stimulation. The company has described ZETA as a GPS-like system for neurosurgery because it is intended to help clinicians understand the position of instruments and anatomy during a procedure. Zeta Surgical expanded its development interests beyond conventional cranial navigation. In 2022, it announced that it was working on a focused-ultrasound system for intracranial drug delivery, with navigation provided by ZETA. The company also became a member of the Focused Ultrasound Foundation. This work positioned the platform as a possible navigation layer for emerging neurological therapies, although the available reference material does not establish that the focused-ultrasound system had reached commercial clearance. A major transition occurred in September 2023, when ZETA received its first FDA 510(k) clearance for use in cranial surgical procedures. The clearance represented the first identified United States regulatory authorization for the company's primary platform. During the same year, the company received an iF Design Award and a Good Design Award. It also partnered with Design + Industry, an Australian product-design and consultancy firm, on product development and design. In 2024, Zeta Surgical obtained additional FDA clearances that broadened the indications and instrument compatibility associated with ZETA. It also received clearance for the Zeta TMS Navigation System, enabling navigated transcranial magnetic stimulation procedures with submillimeter positioning. The company reported completing its first multicenter trial at Singapore General Hospital and Tan Tock Seng Hospital, providing an international clinical-development milestone. Funding reported in public reference material has come from investors and backers including Y Combinator, Artesian Hostplus VC, Innospark Ventures, Trevor Fetter, Gabriel Hammond, and Marc de Garidel. The company has identified advisors including Elad Levy and George Bickerstaff, a former chief financial officer of Novartis Pharma AG. Amich and Sha were included on the North American Forbes 30 Under 30 list for 2024, while Sha had previously been recognized among Harvard's Most Interesting Seniors. Zeta Surgical remains privately held. Publicly available material does not provide a complete account of its financing totals, commercial revenues, workforce, distribution network, or current leadership titles.

• 2024

  Expanded FDA clearances

  [1]Zeta Surgicalen.wikipedia.org

  Additional clearances expanded ZETA's indications and compatible instruments.

• 2024

  Singapore multicenter trial completed

  [1]Zeta Surgicalen.wikipedia.org

  The company reported completion of its first multicenter trial at Singapore General Hospital and Tan Tock Seng Hospital.

• 2023

  First FDA 510(k) clearance

  [1]Zeta Surgicalen.wikipedia.org

  ZETA received its first FDA 510(k) clearance for cranial surgical procedures.

• 2023

  Design awards

  [1]Zeta Surgicalen.wikipedia.org

  Zeta Surgical received an iF Design Award and a Good Design Award.

• 2022

  Focused-ultrasound navigation announced

  [1]Zeta Surgicalen.wikipedia.org

  The company announced development of a focused-ultrasound system for intracranial drug delivery navigated by ZETA.

• 2018

  Company founded

  [1]Zeta Surgicalen.wikipedia.org

  Jose Amich, Raahil Sha, and William Gormley founded Zeta Surgical to develop computer-assisted systems for neurosurgery and related neurological procedures.

An AI- and computer-vision-enabled surgical-navigation company seeking to provide flexible, high-precision, GPS-like guidance for neurosurgery and related neurological procedures.

• Computer-assisted neurosurgical navigation · 2023

  ZETA

  ZETA is Zeta Surgical's principal navigation platform for cranial surgery and related neurological procedures. It combines computer vision, artificial-intelligence algorithms, image registration, and patient tracking to provide real-time spatial guidance. The system is designed to achieve submillimeter accuracy without rigid head fixation and has been evaluated in applications such as neurotrauma, intracerebral hemorrhage, brain biopsy, and transcranial magnetic stimulation. It received FDA clearance in 2023 and additional clearances in 2024.

• Transcranial magnetic stimulation navigation · 2024

  Zeta TMS Navigation System

  The Zeta TMS Navigation System applies Zeta Surgical's navigation technology to transcranial magnetic stimulation. Its FDA-cleared use supports navigated procedures intended to provide submillimeter positioning guidance. The system extends the company's platform beyond open cranial surgery into a noninvasive neurological-treatment workflow, although the available reference material does not specify commercial availability, pricing, or distribution arrangements.

• Focused-ultrasound navigation · 2022

  Focused-ultrasound intracranial drug-delivery navigation system

  Announced in 2022, this development program was intended to use ZETA navigation with focused ultrasound for intracranial drug delivery. The concept reflects Zeta Surgical's interest in supporting emerging image-guided neurological therapies. The available source describes the system as under development and does not establish regulatory clearance, commercialization, clinical availability, or a final product name.

• 2024

  Broaden ZETA indications and compatibilityGeneration change

  Background

  Following the initial 2023 clearance, the company pursued broader clinical and instrument support for its navigation platform.

  Action taken

  Zeta Surgical obtained additional FDA clearances expanding ZETA's indications and compatible instruments.

  Aftermath

  The clearances increased the scope of the platform's regulated use, although the source does not enumerate every newly covered indication or instrument.

  Source

• 2024

  Introduce the Zeta TMS Navigation SystemProduct launch

  Background

  Zeta Surgical extended its navigation technology to transcranial magnetic stimulation procedures.

  Action taken

  The company received FDA clearance for the Zeta TMS Navigation System.

  Aftermath

  The clearance broadened the company's regulated product scope beyond cranial surgical navigation into navigated transcranial magnetic stimulation.

  Source

• 2023

  Regulatory introduction of ZETA for cranial surgeryProduct launch

  Background

  The company's primary navigation platform reached a regulatory milestone after years of technical and clinical development.

  Action taken

  ZETA received its first FDA 510(k) clearance for cranial surgical procedures.

  Aftermath

  The clearance established a regulated pathway for the platform's use in cranial surgical procedures in the United States.

  Source

• 2022

  Expand into focused-ultrasound drug deliveryStrategy

  Background

  Zeta Surgical identified a potential application for its navigation platform in focused ultrasound and intracranial drug delivery.

  Action taken

  The company announced development of a focused-ultrasound system navigated by ZETA and joined the Focused Ultrasound Foundation.

  Aftermath

  The available material records the development direction but does not report a commercial launch or regulatory clearance for the system.

  Source

• 2024

  Additional FDA clearances expand ZETA indications and instrument compatibility[1]Zeta Surgicalen.wikipedia.org

  Regulation · Product generation

  Further United States regulatory clearances expanded the clinical indications and compatible instruments associated with the ZETA platform.

• 2024

  Zeta Surgical reports clearance for Zeta TMS Navigation System[1]Zeta Surgicalen.wikipedia.org

  Regulation · Product launch

  The company received FDA clearance for a navigation system supporting submillimeter navigated transcranial magnetic stimulation procedures.

• 2024

  Zeta Surgical completes first multicenter trial in Singapore[1]Zeta Surgicalen.wikipedia.org

  Other

  Zeta Surgical reported completion of its first multicenter trial at Singapore General Hospital and Tan Tock Seng Hospital.

• 2023

  ZETA receives first FDA 510(k) clearance for cranial surgical procedures[1]Zeta Surgicalen.wikipedia.org

  Regulation · Product launch

  Zeta Surgical's primary navigation platform received its first United States FDA 510(k) clearance for cranial surgical procedures.

• 2023

  Zeta Surgical receives design recognition for its navigation technology[1]Zeta Surgicalen.wikipedia.org

  Other

  The company received an iF Design Award and a Good Design Award for its work related to the ZETA platform.

1. 1Zeta Surgicalen.wikipedia.org