ClaroNav Received EU Certification for Navigation System
Hospitals can now utilize the Navient system under EU MDR to improve surgical imaging workflows.
Updated on Oct. 7, 2026 in Healthcare
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ClaroNav Kolahi Inc. has received European Union Medical Device Regulation (EU MDR) certification for its Navient Surgical Navigation System. This certification covers the image-guided system and its associated reusable instruments across the European market.
Why it matters
The system allows hospitals to leverage existing 2D C-arm equipment for advanced 3D navigation, reducing the need for high-cost hardware investments. By integrating preoperative CT and MRI data with real-time fluoroscopy, providers can reduce surgical workflow complexity and patient radiation exposure.
The Navient system currently maintains an installed base of more than 250 systems across 70 countries. The new EU MDR approval upgrades the product from previous EU MDD standards, adding to existing regulatory clearances from the FDA, Health Canada, China NMPA, and Japan PMDA.
The players
ClaroNav Kolahi Inc.
A Toronto-based medical technology company that develops surgical navigation software and hardware systems for global hospital markets.
The details
The platform works by using the FluoroGuide 2D interface to map preoperative CT and MRI scans directly onto intraoperative 2D fluoroscopy feeds. This technical integration enables surgeons to achieve 3D navigation accuracy without requiring specialized new imaging machines. The process effectively repurposes standard hospital C-arm equipment, which lowers the barrier to entry for facilities aiming to modernize their surgical suites.
Timeline
October 7, 2026: ClaroNav Kolahi Inc. announced the receipt of EU MDR certification.
Market Landscape
This certification marks a successful transition for the company to the current, more rigorous EU MDR standards. It follows a broader industry trend where manufacturers must recertify legacy products to maintain access to the European healthcare market.
Hospital operators should evaluate whether integrating the Navient platform with existing C-arm equipment can reduce current surgical capital expenditures. Facility managers should review the system specifications to determine if it meets local clinical requirements for 3D image-guided navigation.
The takeaway
Adopting navigation tools that maximize existing imaging infrastructure is a key strategy for managing medical device budgets. Operations managers should track similar regulatory filings to identify which surgical technologies will be legally viable in their jurisdiction over the next three years.
Further reading
For more on industry regulatory changes, see Healthcare.
More information
To review the full specifications of the system, visit the ClaroNav medical technology website.
Live Poll
Should local hospitals prioritize investing in new surgical navigation technology to reduce patient radiation exposure?
