SurgVision

Netherlands · www.braccoimaging.com/en/products/fluorescence-imaging · 6 vendors

Resilience scores

Technology vendors

Services catalogue

1 service in catalogue across 1 category; runs on 6 sub-vendors.

Insights

Last updated 2026-09-12 · revision 2

6 direct vendors, 72 subvendors

Direct vendors by controlling owner country (sample)

Subvendors by controlling owner country (sample)

Migration Readiness: 3/10

Assessed by AI based on technology stack characteristics (cloud-native vs legacy, containerization, microservices), regulatory environment, data residency requirements, financial stability, and vendor lock-in risks. The score ranges from 0-10, where higher scores indicate better readiness for technology migration.

SurgVision's migration readiness is assessed as low, primarily due to the extensive lack of critical information and the explicit "Unknown" status of key risk factors. The most significant challenge is the complete absence of data regarding the "Internal Tech Stack" and "Key Technologies." Without knowing if the current infrastructure is legacy, monolithic, or already cloud-native, containerized, or microservices-based, it's impossible to plan or estimate the complexity and cost of a migration. Similarly, the "Regulatory Environment" and "Data Residency Requirements" are either unknown or not specified, which are crucial factors that can significantly impact migration strategy, compliance, and cost. The "Vendor Lock-in Risk" is explicitly "Unknown," which is a major red flag. If there is significant vendor lock-in (e.g., proprietary technologies, complex contracts, or a small number of vendors providing many critical services), it would severely impede migration efforts. The financial stability required to fund a potentially large-scale migration is also unknown due to missing revenue and growth data. The only potentially positive, albeit unconfirmed, aspect is the "Vendor Geographic Diversity" across 2 countries, which might suggest some level of vendor choice, though the actual number of unique vendors for the 5 services is unclear due to the conflicting "Total Vendors: 0" data point. If the actual number of unique vendors is low, it could increase lock-in. The overwhelming lack of information across technology, regulatory, data residency, and financial domains, combined with the unknown vendor lock-in risk, indicates a very low state of migration readiness. Any migration attempt would face substantial unforeseen challenges and risks.

Compliance

6 in-scope frameworks identified; showing 3.

FDA Medical Device Regs — Compliant

SurgVision markets its EXPLORER AIR® II device in the United States. The company has received multiple 510(k) clearances from the U.S. Food and Drug Administration for this device, indicating its compliance with relevant regulations.

Failure to maintain FDA clearance would block access to the U.S. market, a critical revenue source for medical technology companies. The FDA's enforcement powers include recalls, seizures, and civil penalties, making compliance essential.

Evidence: https://www.biospace.com/article/releases/surgvision-s-explorer-air-ii-receives-510-k-clearance-by-the-u-s-food-and-drug-administration/, https://www.medicaldevice-network.com/news/us-fda-issues-510k-approval-to-surgvisions-explorer-air-ii-device/, https://www.accessdata.fda.gov/cdrh_docs/pdf21/K214097.pdf, https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222240.pdf, https://www.fda.report/PMN/K230891, https://www.medicaldevice-network.com/news/fda-surgvision-explorer-air-ii-device/

ISO 13485 — Compliant

As a manufacturer of medical devices for the EU and US markets, a certified Quality Management System is a regulatory and commercial necessity. SurgVision's own website confirms its ISO 13485 certification.

ISO 13485 certification is a de facto requirement for medical device manufacturers to gain market access in the EU, Canada, and other major jurisdictions. Lack of certification would severely hinder commercialization efforts and erode customer trust.

Evidence: https://www.surgvision.com/, https://www.nsf.org/medical-devices/quality-management-systems/iso-13485, https://vvdntech.com/blog/iso-13485-certification/, https://www.inspital.com/en/blog/certifications-in-medical-technology-a-guide-to-iso-13485-co, https://www.nsf.org/management-systems/quality-management/iso-13485, https://www.vvdntech.com/blog/iso-13485-certification/

GDPR (source) — Partially Compliant

SurgVision is headquartered in the Netherlands, an EU member state. Therefore, it is subject to the General Data Protection Regulation for all its personal data processing activities, including employee and customer data.

As an EU-based company, GDPR compliance is mandatory. While there is no evidence of non-compliance, the lack of a publicly identified Data Protection Officer and limited public information on data processing activities presents a potential risk.

Evidence: https://tracxn.com/d/companies/surgvision/__ivyA1y22IuDk2EEScI7uW5qjYcT7SjB9k8vO6L3n2U, https://www.bracco.com/en/the-group/our-businesses, https://www.tvh-business.nl/surgvision/, https://tracxn.com/d/companies/surgvision/__Jvf0wbvnMoC8uEM1pduNS6gEj4SbkvUfGo_P0TNRNb4, https://www.bracco.com/our-businesses, https://www.tvh-business.com/surgvision/

Financials

Three-year financials

Financial Resilience Score: 7/10

SurgVision B.V. benefits from strong parent backing as a wholly-owned subsidiary of Bracco Imaging S.p.A. (part of the Bracco Group), a large privately held Italian pharmaceutical and imaging group with multi-billion-euro annual revenues (Group revenue in the €1.4–1.7 billion range in recent years) and a diversified diagnostic-imaging franchise. This parent relationship provides access to capital, distribution networks, regulatory expertise, and R&D infrastructure that far exceed what a standalone start-up would have available, materially strengthening SurgVision's financial resilience. However, standalone financial visibility is limited. As a private subsidiary of a private parent, SurgVision does not publish standalone audited financials, and its Dutch KVK filings typically include only abbreviated balance-sheet information. Pre-acquisition, SurgVision was a small R&D-stage company, and standalone profitability likely depends heavily on parent funding and internal transfer pricing arrangements. Strategic positioning in the growing fluorescence-guided surgery (FGS) niche aligned with Bracco's core imaging expertise, combined with strong academic ties to UMCG, supports long-term viability. Nevertheless, the business remains narrowly focused, dependent on FGS adoption in oncology surgery, and faces significant competition from larger players including Stryker/Novadaq, Karl Storz, Olympus, Intuitive Surgical, and Hamamatsu. Revenue upside is also tied to regulatory approval timelines for co-developed tracers.

Key strengths: Strong parent backing from Bracco Group (multi-billion-euro Italian pharma/imaging group), Access to Bracco's global distribution, capital, and R&D infrastructure, Strategic positioning in growing fluorescence-guided surgery niche, Academic pedigree and clinical research pipeline from UMCG origins, Aligned with Bracco's core diagnostic imaging expertise

Risk factors: Narrow product/market concentration in fluorescence imaging systems, Competitive market with larger players (Stryker/Novadaq, Karl Storz, Olympus, Intuitive Surgical, Hamamatsu), Regulatory and clinical dependency on tracer co-development timelines (bevacizumab-800CW, cetuximab-800CW, ONM-100), Opaque standalone financials as private subsidiary of private parent, Small entity risk - likely dependent on parent funding and internal transfer pricing, FGS market still maturing with uncertain adoption trajectory

Workforce by country

Signed-in users can see whether their own company is exposed to this vendor's disruption, plus the full sub-vendor list and country breakdowns, every in-scope compliance framework plus gaps and next steps, and alerts when any of it changes.

View the full interactive report