Surgical Theater
More actions
| Surgical Theater | |
|---|---|
| Information | |
| Industry | Medical technology, extended reality |
| Founded | 2010 |
| Founder | Moty Avisar, Alon Geri |
| Headquarters | Beachwood, Ohio, United States |
| Notable Personnel | Moty Avisar (co-founder), Alon Geri (co-founder), Alon Zuckerman (president) |
| Products | SyncAR Spine, SyncAR Cranial, PlanXR, BrainSTORM, XR Studio, ConveyXR |
| Website | https://surgicaltheater.com |
Surgical Theater is an American medical technology company that turns a patient's CT and MRI scans into interactive 3D models that surgeons can view on a touchscreen, in a virtual reality headset or as an augmented reality overlay in the operating room. It was founded in 2010 by Moty Avisar and Alon Geri, two former Israeli Air Force officers who had worked on flight simulators, and started out as a Cleveland-based startup.[1][2] The company's legal name is Surgical Theater, Inc., and its office is in Beachwood, Ohio.[3]
The company began with a neurosurgery rehearsal system, the Surgery Rehearsal Platform, which the U.S. Food and Drug Administration (FDA) cleared in February 2013. Later products added VR headsets for planning and, from 2022, AR headsets for spine surgery. Between 2013 and 2025 the company received eight FDA 510(k) clearances.[4] HTC invested in its 9 million US dollar Series A round in 2015 and contributed HTC Vive headset technology,[5] and in 2021 Medtronic partnered with the company to connect its SyncAR software to Medtronic's StealthStation S8 navigation system.[6]
History
Founding and first product
Avisar and Geri were working in Cleveland on a U.S. Air Force flight simulation system when Warren Selman, chair of neurosurgery at Case Western Reserve University, overheard them talking and asked whether surgeons could be given the kind of view of an operation that pilots get of a mission. Avisar told Smithsonian magazine that surgeons wanted to "fly inside the brain."[7] A 2014 Fox News report described Avisar as having spent 20 years overseeing large flight simulator research and development projects and Geri as a former Israeli Air Force research and development officer; Selman was the company's medical director.[8] MedCity News reported that the company was launched in 2010 with angel and private funding.[2]
In January 2012 MedCity News described Surgical Theater as a startup largely funded by angel investors, with a 100,000 US dollar grant from the Innovation Fund of the Lorain County Community College Foundation. Its first product was personalized simulation software that loaded a patient's MRI or CT images and let a surgeon rehearse brain aneurysm surgery with modeled tools; Selman was helping to develop it. The company aimed to sell it to the residency programs of medical education institutions.[9] A 2013 paper by University Hospitals Case Medical Center neurosurgeons in Neurosurgery described the system, then called the Selman Surgical Rehearsal Platform, and its possible use for training in intracranial microvascular surgery.[10]
The FDA cleared the Surgery Rehearsal Platform on 8 February 2013 as a pre-operative tool for simulating and evaluating surgical treatment options. The clearance letter addressed Mordechai Avisar as CEO, president and co-founder, at an office in Elyria, Ohio.[11][12] The second product, the Surgical Navigation Advanced Platform (SNAP), was cleared on 27 June 2014. Unlike the rehearsal platform, SNAP was also meant for use during surgery: it received position data from a third-party navigation system and showed the navigation pointer inside the 3D model.[13] NYU Langone Medical Center announced in June 2014 that its neurosurgeons were using the rehearsal platform, which it said could help in surgery for conditions including pituitary, skull base and intrinsic brain tumors, aneurysms and arteriovenous malformations.[12]
Move to VR headsets (2015-2019)
In May 2015 CBS News reported that UCLA neurosurgery chair Neil Martin was developing virtual reality headset technology with Avisar, then the company's CEO, and that it was to be introduced at the American Association of Neurological Surgeons annual meeting that month.[14] By September 2015, Smithsonian reported, SNAP was designed for the HTC Vive and the Oculus Rift, neither of which had yet gone on public sale. A model of the vascular system took as little as five minutes to build, and complex structures such as tumors up to 20 minutes. Surgeons in Europe were using SNAP during operations, while in the United States it was then a planning and research tool.[7]
On 19 October 2015 MedCity News reported that the company had closed a 9 million US dollar Series A round funded by HTC and Shanghai Creation Investment Management, and that it was adding HTC's Vive headset to its VR tools. HTC chief executive Cher Wang called the collaboration "an exciting opportunity to pioneer the medical use of VR". At the time, the software was being tested at UCLA, New York University, Mayo Clinic, Rainbow Babies and Children's Hospital and Cleveland Clinic.[5] In April 2016 Martin and Geri, then the company's executive vice president of engineering, presented the HTC Vive version at the NVIDIA GPU Technology Conference.[15]
The FDA cleared a modified SNAP on 28 June 2016. Its 510(k) summary listed the other trade names "VR SNAP" and "Endo SNAP" and added a VR headset that gives a stereoscopic view of the same 3D scene shown on the touchscreen; after testing, the headset was labeled for both pre-operative and intra-operative use.[16] In July 2016 Stanford University's neurosurgery department installed the company's Precision VR platform, which was used to show patients and families their own anatomy, either on a touchscreen or in an Oculus Rift or HTC Vive headset. Stanford neurosurgery chair Gary Steinberg said the department saw "tremendous value in utilizing virtual reality across our treatment continuum".[17][18]
UploadVR reported in August 2016 that Hoag Memorial Hospital Presbyterian, one of ten hospitals then using the technology, had used SNAP on 100 patients with an Oculus Rift DK2 headset, and that the company counted more than 2,000 patients treated with its technology. Hoag neurosurgeon Robert Louis was to begin testing a new AR technology from the company in the operating room in September 2016.[19] The SuRgical Planner (SRP), cleared in February 2018, likewise added a VR headset and controllers to the rehearsal software.[20] In June 2019 Israel's Ministry of Health approved SNAP and SRP for sale in Israel, and the company appointed Eli Moshe as senior vice president and general manager for Europe and the Middle East.[21]
Augmented reality (2020-present)
The SRP BrainStorm version, cleared in July 2020, added support for an AR headset alongside VR.[22] On 26 April 2021 Medtronic announced a partnership to integrate Surgical Theater's SyncAR with its StealthStation S8 surgical navigation system, so that a 360-degree AR rendering could be overlaid on the live surgical site during brain surgery. The release, which named Avisar as CEO and co-founder, said the company's technology had supported more than 15,000 surgeries and been used in over 100,000 patient consultations.[6] A 2021 case series in Operative Neurosurgery from Hoag, Stanford, Houston Methodist and other centers described 49 patients whose 360-degree models were used for VR planning and then injected through SyncAR into the oculars of Zeiss or Leica surgical microscopes, co-registered with the StealthStation S8.[23]
The company's first spine product, SpineAR SNAP, was cleared on 29 September 2022 for spinal implant procedures such as pedicle screw placement, with the AR view shown in a Magic Leap 1 or HoloLens 2 headset. The 3D scene is projected above the patient so that it does not block the surgeon's view.[24] In October 2023 the company announced the first surgery with the product, now marketed as SyncAR Spine: a spinal tumor resection at Stanford Medicine led by neurosurgeon Atman Desai using a HoloLens 2.[25][26] A December 2024 clearance extended HoloLens 2 use from the lumbar to the thoracic spine.[27]
The latest clearance, on 29 September 2025, covered software version SPR.2.0.0 of SyncAR Spine. It added machine-learning vertebra segmentation based on a 3D U-Net neural network, and it dropped the Magic Leap 1 because that headset is "no longer supported by the manufacturer", leaving HoloLens 2 as the only AR headset in the indications.[28] Announcing the clearance on 10 October 2025, the company said its XR technologies had been used clinically more than 50,000 times, and that OrthoIndy spine surgeon Greg Poulter had performed the first case with the new version.[29][30] As of October 2026 the company's website lists Alon Zuckerman as president.[3]
FDA clearances
All of the company's U.S. clearances are 510(k) premarket notifications found "substantially equivalent" to an earlier device. The applicant was listed as Surgical Theater, LLC through the 2017 submission and as Surgical Theater, Inc. from 2020. By submission year, its address moved from Elyria (2012) to Mayfield Village (2014-2020), Pepper Pike (2021) and Beachwood, Ohio (2024-2025).[4]
| 510(k) | Device name | Decision date | XR-related change |
|---|---|---|---|
| K123023 | Surgery Rehearsal Platform | 8 February 2013 | First clearance; pre-operative simulation on a PC workstation[11] |
| K140819 | Surgical Navigation Advanced Platform | 27 June 2014 | Pre- and intra-operative use with external navigation systems[13] |
| K160584 | Surgical Navigation Advanced Platform (SNAP) | 28 June 2016 | VR headset added, labeled for pre- and intra-operative use[16] |
| K170793 | SuRgical Planner (SRP) | 12 February 2018 | VR headset and controllers added[20] |
| K201465 | SuRgical Planner (SRP) BrainStorm | 17 July 2020 | AR headset support added[22] |
| K213034 | SpineAR SNAP | 29 September 2022 | AR guidance for spinal implant procedures with Magic Leap 1 or HoloLens 2[24] |
| K243623 | SpineAR SNAP (SyncAR Spine) | 24 December 2024 | HoloLens 2 use extended to the thoracic region[27] |
| K252054 | SpineAR SNAP (SyncAR Spine) | 29 September 2025 | AI/ML vertebra segmentation; Magic Leap 1 removed[28] |
Products
The company's 2026 website groups its products under an "eXperiential Reality" platform that, in its words, uses AI "to transform traditional 2D scans into interactive 3D models".[31]
| Product | Use (as described by the company) |
|---|---|
| PlanXR | Pre-operative exploration of a patient's anatomy in XR to locate potential risks[31] |
| SyncAR Spine | Brings the surgeon's plan into spine surgery; integrates with Medtronic StealthStation navigation and a HoloLens 2 headset[31][28] |
| SyncAR Cranial | Intra-operative AR for cranial surgery[31][6] |
| BrainSTORM | Visualizes an epilepsy patient's data on one platform[31] |
| XR Studio | Multi-user environment for patient-specific case reviews in XR headsets[31] |
| ConveyXR | Patient engagement tool that delivers patient-specific XR reconstructions to the patient[31] |
Earlier product names included Precision VR, the 2016 patient-engagement platform, and SynchronizAR, an AR product listed in the company's 2019 press material.[18][21]
Research
Several peer-reviewed studies have looked at the company's systems, often with authors from customer hospitals. In a randomized trial at University Hospitals Case Medical Center published in the Journal of Neurosurgery in 2017, 25 analyzed aneurysm clipping operations (of 40 randomized patients) were compared with and without prior rehearsal on the SuRgical Planner. The rehearsal group had a lower mean operative time per clip used (920 versus 1,294 seconds, p = 0.05); its other measures were lower on average, but those differences were not statistically significant.[32] A 2021 set of five case reports from Stanford, Hoag, Hackensack Meridian JFK Medical Center and NYU described 360-degree VR models made with Surgical Theater being used for patient consultation, planning and intra-operative navigation; in two cases the surgical plan changed after review of the model. Two of the authors reported personal fees from the company.[33]
See also
References
- ↑ Betty Ilovici (2014-12-25). "Inspired By Israeli Air Force Simulators, Former Pilots Develop 3D Brain Simulator for Surgeons". NoCamels. https://nocamels.com/2014/12/surgeon-3d-brain-simulator-pilots/. Retrieved 2026-10-13.
- ↑ 2.0 2.1 Meghana Keshavan (2015-07-14). "Surgical Theater: Using virtual reality as a surgical tool". MedCity News. https://medcitynews.com/2015/07/surgical-theater-using-virtual-reality-as-a-surgical-tool/. Retrieved 2026-10-13.
- ↑ 3.0 3.1 "About". Surgical Theater. https://surgicaltheater.com/about/. Retrieved 2026-10-13.
- ↑ 4.0 4.1 "510(k) records for applicant Surgical Theater". openFDA. U.S. Food and Drug Administration. https://api.fda.gov/device/510k.json?search=applicant:%22surgical+theater%22&limit=50. Retrieved 2026-10-13.
- ↑ 5.0 5.1 Meghana Keshavan (2015-10-19). "HTC funds virtual reality startup Surgical Theater in $9M Series A". MedCity News. https://medcitynews.com/2015/10/htc-surgical-theater/. Retrieved 2026-10-13.
- ↑ 6.0 6.1 6.2 "Medtronic Partners with Surgical Theater to Provide First Augmented Reality Platform for Use in Real-Time During Complex Cranial Procedures". Medtronic News. Medtronic. 2021-04-26. https://news.medtronic.com/2021-04-26-Medtronic-Partners-with-Surgical-Theater-to-Provide-First-Augmented-Reality-Platform-for-Use-in-Real-Time-During-Complex-Cranial-Procedures. Retrieved 2026-10-13.
- ↑ 7.0 7.1 Michelle Z. Donahue (2015-09-15). "How Is Brain Surgery Like Flying? Put On a Headset to Find Out". Smithsonian. https://www.smithsonianmag.com/innovation/how-brain-surgery-flying-put-headset-find-out-180956592/. Retrieved 2026-10-13.
- ↑ Loren Grush (2014-04-02). "Surgical Theater: Flight simulation technology helps surgeons prep for surgery". Fox News. https://www.foxnews.com/health/surgical-theater-flight-simulation-technology-helps-surgeons-prep-for-surgery. Retrieved 2026-10-13.
- ↑ Brandon Glenn (2012-01-03). "'Patient-specific' surgical simulation startup readies for market". MedCity News. https://medcitynews.com/2012/01/patient-specific-surgical-simulation-startup-readies-for-market/. Retrieved 2026-10-13.
- ↑ N. C. Bambakidis, W. R. Selman, A. E. Sloan (2013-10). "Surgical rehearsal platform: potential uses in microsurgery". Neurosurgery, vol. 73, suppl. 1, pp. 122-126. https://doi.org/10.1227/NEU.0000000000000099. Retrieved 2026-10-13.
- ↑ 11.0 11.1 "K123023 Surgery Rehearsal Platform: 510(k) clearance letter and summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2013-02-08. https://www.accessdata.fda.gov/cdrh_docs/pdf12/K123023.pdf. Retrieved 2026-10-13.
- ↑ 12.0 12.1 "New 'Flight Simulator' Technology Gives NYU Langone Neurosurgeons a Peek Inside Brain Before Surgery". NYU Langone News. NYU Langone Health. 2014-06-19. https://nyulangone.org/news/new-flight-simulator-technology-gives-nyu-langone-neurosurgeons-peek-inside-brain-surgery. Retrieved 2026-10-13.
- ↑ 13.0 13.1 "K140819 Surgical Navigation Advanced Platform: 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2014-06-27. https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140819.pdf. Retrieved 2026-10-13.
- ↑ "Latest tool for neurosurgeons: Virtual reality headsets". CBS News. 2015-05-04. https://www.cbsnews.com/news/virtual-reality-headsets-for-neurosurgeons-ucla-dr-neil-martin-moty-avisar/. Retrieved 2026-10-13.
- ↑ "Surgical Theater Unveils Medical Virtual Reality Visualization at NVIDIA GPU Technology Conference". Halldale Group. 2016-04-06. https://www.halldale.com/safety-critical-industries/13114-surgical-theater-unveils-medical-virtual-reality-visualization-at-nvidia-gpu-technology-conference. Retrieved 2026-10-13.
- ↑ 16.0 16.1 "K160584 Surgical Navigation Advanced Platform (SNAP): Special 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2016-06-28. https://www.accessdata.fda.gov/cdrh_docs/pdf16/K160584.pdf. Retrieved 2026-10-13.
- ↑ "Surgical Theater installs VR software at Stanford". AuntMinnie. 2016-07-17. https://www.auntminnie.com/imaging-informatics/advanced-visualization/image-guided-surgery/article/15615374/surgical-theater-installs-vr-software-at-stanford. Retrieved 2026-10-13.
- ↑ 18.0 18.1 "Stanford Neurosurgery Using Surgical Theater's Precision VR to Advance Patient Engagement". Halldale Group. 2016-07-18. https://www.halldale.com/articles/13195-stanford-neurosurgery-using-surgical-theater-s-precision-vr-to-advance-patient-engagement. Retrieved 2026-10-13.
- ↑ John Gaudiosi (2016-08-28). "How Surgical Theater Changes The Way Neurosurgeons Operate". UploadVR. https://www.uploadvr.com/surgical-theater-neurosurgeons/. Retrieved 2026-10-13.
- ↑ 20.0 20.1 "K170793 SuRgical Planner (SRP): 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2018-02-12. https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170793.pdf. Retrieved 2026-10-13.
- ↑ 21.0 21.1 "Surgical Theater Received Approval to Market the Surgical Navigation Advanced Platform (SNAP) and SuRgical Planner (SRP) Systems from the Israeli Ministry of Health". PR Newswire. Surgical Theater. 2019-06-24. https://www.prnewswire.com/il/news-releases/surgical-theater-received-approval-to-market-the-surgical-navigation-advanced-platform-snap-and-surgical-planner-srp-systems-from-the-israeli-ministry-of-health-829871316.html. Retrieved 2026-10-13.
- ↑ 22.0 22.1 "K201465 SuRgical Planner (SRP) BrainStorm: 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2020-07-17. https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201465.pdf. Retrieved 2026-10-13.
- ↑ R. G. Louis, G. K. Steinberg, C. Duma, et al. (2021-09-15). "Early Experience With Virtual and Synchronized Augmented Reality Platform for Preoperative Planning and Intraoperative Navigation: A Case Series". Operative Neurosurgery, vol. 21, no. 4, pp. 189-196. https://doi.org/10.1093/ons/opab188. Retrieved 2026-10-13.
- ↑ 24.0 24.1 "K213034 SpineAR SNAP: 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2022-09-29. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K213034.pdf. Retrieved 2026-10-13.
- ↑ Julie Vetalice (2023-10-23). "First Case with Surgical Theater's SyncAR Spine". ORTHOWORLD. https://www.orthoworld.com/first-augmented-spine-surgery-with-surgical-theaters-syncar-spine/. Retrieved 2026-10-13.
- ↑ Jeffrey Ziegler (2023-12-09). "AR in medicine: Spinal surgery via Hololens 2 shows the future of medicine". MIXED. https://mixed-news.com/en/ar-surgery-hololens-future-of-medicine/. Retrieved 2026-10-13.
- ↑ 27.0 27.1 "K243623 SpineAR SNAP (SyncAR Spine): 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2024-12-24. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243623.pdf. Retrieved 2026-10-13.
- ↑ 28.0 28.1 28.2 "K252054 SpineAR SNAP (SyncAR Spine): 510(k) summary". FDA 510(k) Premarket Notification database. U.S. Food and Drug Administration. 2025-09-29. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252054.pdf. Retrieved 2026-10-13.
- ↑ "Surgical Theater Secures FDA Clearance for AI-Enhanced SyncAR Spine Surgical Visualization Platform". G-Medtech. 2025-10-10. https://g-medtech.com/news/surgical-theater-secures-fda-clearance-for-ai-enhanced-syncar-spine-surgical-visualization-platform/. Retrieved 2026-10-13.
- ↑ Patrick McGuire (2025-10-10). "Surgical Theater Receives FDA Clearance for SyncAR Spine". ORTHOWORLD. https://www.orthoworld.com/surgical-theater-receives-fda-clearance-for-syncar-spine/. Retrieved 2026-10-13.
- ↑ 31.0 31.1 31.2 31.3 31.4 31.5 31.6 "Surgical Theater". Surgical Theater. https://surgicaltheater.com/. Retrieved 2026-10-13.
- ↑ A. J. Chugh, J. R. Pace, J. Singer, et al. (2017-03). "Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial". Journal of Neurosurgery, vol. 126, no. 3, pp. 838-844. https://doi.org/10.3171/2016.1.JNS152576. Retrieved 2026-10-13.
- ↑ D. Anthony, R. G. Louis, Y. Shekhtman, et al. (2021-06-07). "Patient-specific virtual reality technology for complex neurosurgical cases: illustrative cases". Journal of Neurosurgery: Case Lessons, vol. 1, no. 23. https://doi.org/10.3171/CASE21114. Retrieved 2026-10-13.