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Zeta Surgical

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American medical technology company.
Zeta Surgical Inc.
Company typePrivate
IndustryMedical devices
Founded2018
FoundersJose Amich (CEO), Raahil Sha (CTO), William Gormley
HeadquartersBoston, Massachusetts, United States
ProductsSurgical navigation
Websitehttps://zetasurgical.com

Zeta Surgical is a privately held American medical technology company based in Boston, Massachusetts. The company develops computer-assisted surgery systems for neurosurgery and interventional neuroradiology. The company was founded in 2018 by Harvard University graduates Jose Amich and Raahil Sha, along with Brigham and Women's Hospital neurosurgeon William Gormley.

Technology

Zeta Surgical's technology employs computer vision and artificial intelligence algorithms for real-time surgical navigation. The company's approach utilizes parallel computing for image registration and patient tracking without rigid head fixation. Preclinical studies have evaluated the system's ability to maintain submillimeter accuracy in applications such as neurotrauma, intracerebral hemorrhage and brain biopsy.

The company's primary product, the Zeta Cranial Navigation System, has been described as a "GPS-like" system for neurosurgery. It received its first 510(k) clearance from the US Food and Drug Administration for use in cranial surgical procedures in September 2023, followed by subsequent clearances in 2024 that expanded its indications and instrument compatibility. In 2024, Zeta Surgical reported the completion of its first multi-center trial at Singapore General Hospital and Tan Tock Seng Hospital. The Zeta Cranial Navigation System received an iF Design Award and a Good Design Award in 2023. The company is partnered with Australian product design and consultancy firm Design + Industry.

In 2022, Zeta Surgical announced that it was developing a Focused ultrasound for intracranial drug delivery system, navigated by the Zeta Cranial Navigation System. The company is a member of the Focused Ultrasound Foundation.

History

Zeta Surgical was started by Jose Amich and Raahil Sha while studying as undergraduate students at Harvard University, together with Harvard Medical School professor William Gormley, also a neurosurgeon at the Brigham and Women's Hospital. Jose Amich and William Gormley are alumni of the MIT Sloan School of Management MBA program. The company has raised funding from notable investors such as Y Combinator, Artesian Hostplus VC, Innospark Ventures, Trevor Fetter, Gabriel Hammond and Marc de Garidel. Zeta Surgical is represented by law firm White & Case LLP.

Raahil Sha was named one of Harvard's Most Interesting Seniors. Together with Jose Amich, they have been recognized on the North American Forbes 30 Under 30 2024 list.

References

  1. ^ Park, Andrea (13 September 2023). "Zeta Surgical zeroes in on FDA nod for 'GPS-like' neurosurgery navigation system". Fierce Biotech. Retrieved 13 June 2024. Zeta Surgical is zeroing in on an FDA clearance for its GPS-like neurosurgery navigation system
  2. ^ "30 Under 30 North America: Jose Amich and Raahil Sha". Forbes. 28 November 2023. Retrieved 13 June 2024.
  3. Chiurillo, I.; Sha, R. M.; Robertson, F. C. (2023). "High-Accuracy Neuro-Navigation with Computer Vision for Frameless Registration and Real-Time Tracking". Bioengineering. 10 (12): 1401. doi:10.3390/bioengineering10121401. PMC 10740492.
  4. Robertson, F. C.; Sha, R. M.; Amich, J. M. (2021). "Frameless neuronavigation with computer vision and real-time tracking for bedside external ventricular drain placement: a cadaveric study". Journal of Neurosurgery. 136 (5): 1475–1484. doi:10.3171/2021.5.JNS211033. hdl:1887/3570569. PMID 34653985.
  5. Robertson, F. C.; Wu, K. C.; Sha, R. M. (2022). "Stereotactic Neurosurgical Robotics With Real-Time Patient Tracking: A Cadaveric Study". Operative Neurosurgery. 22 (6): 425–432. doi:10.1227/ons.0000000000000155. hdl:1887/3570570. PMID 35867082.
  6. "510(k) Premarket Notification (K230661)" (PDF). U.S. Food & Drug Administration. 8 September 2023. Retrieved 13 November 2024.
  7. "Zeta Surgical secures first FDA clearance for robotic surgery system". Boston Business Journal. 11 September 2023. Retrieved 13 June 2024.
  8. "510(k) Premarket Notification (K233903)" (PDF). U.S. Food & Drug Administration. 10 January 2024. Retrieved 13 November 2024.
  9. "510(k) Premarket Notification (K242351)" (PDF). U.S. Food & Drug Administration. 4 October 2024. Retrieved 13 November 2024.
  10. "Zeta Surgical nabs expanded FDA clearance ahead of brain surgery navigation system rollout". Fierce Biotech. 11 November 2024. Retrieved 13 November 2024.
  11. "Zeta Surgical sees positive results in guided neurosurgery trial". Medical Device Network. 7 June 2024. Retrieved 13 June 2024.
  12. "Zeta Cranial Navigation System". iF Design Award. 2023. Retrieved 13 June 2024.
  13. "Zeta Surgical Neurosurgical Navigation System". Good Design Award. 2023. Retrieved 13 June 2024.
  14. "Zeta Surgical". Design + Industry. Retrieved 13 June 2024.
  15. AiThority (22 January 2024). "Zeta Surgical Appoints Professor James Choi as Focused Ultrasound Lead in Push for Incision-Less Brain Surgery". AiThority. Retrieved 13 June 2024.
  16. "State of the Field Report 2024: Chapter 8 - FUS Industry" (PDF). Focused Ultrasound Foundation. July 2024. Retrieved 13 June 2024.
  17. ^ "Emles Venture Partners". Retrieved 13 June 2024.
  18. "Forbes 30 Under 30 List Spotlights 35 from MIT". MIT Alumni Association. 14 December 2023. Retrieved 13 June 2024.
  19. "Clinical and Scientific Advisors". CoaguloMed. Retrieved 13 June 2024.
  20. "Zeta Surgical comes out of stealth with a $5.2M raise for image-guided surgery". TechCrunch. 10 March 2022. Retrieved 13 June 2024.
  21. "White & Case Advises Zeta Surgical Inc. on Preferred Stock Financing". White & Case LLP. 5 March 2024. Retrieved 13 June 2024.
  22. "The Most Interesting Seniors in the Harvard Class of 2018". The Harvard Crimson. 21 June 2018. Retrieved 13 June 2024.


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