TORONTO--(BUSINESS WIRE)--ClaroNav Kolahi Inc. (CKI), a global developer and manufacturer of surgical navigation technologies, today announced that its Navient Surgical Navigation System has received certification under the European Union Medical Device Regulation, EU MDR.
ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System
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Spine SurgeryClaroNAV Kohahi IncNavient Surgical Navigation SystemcertificationEuropean Union Medical Device RegulationEU MDR
ClaroNav Kolahi Inc. Announces EU MDR Certification for Navient Surgical Navigation System
The certification covers the Navient Image Guided Navigation System and its reusable surgical instruments, allowing CKI to continue offering Navient throughout the European Union under the EU MDR regulatory framework.
“EU MDR certification is an important milestone for CKI and demonstrates our continued commitment to meeting the highest standards for safety, quality, and regulatory compliance,” said Ahmad Kolahi, CEO of CKI.
Navient was previously certified under EU MDD and has received regulatory approvals including US FDA, Health Canada, China NMPA, and Japan PMDA. Today, Navient is installed in more than 70 countries, with an installed base of more than 250 systems worldwide.
For spine surgery, CKI has expanded the Navient platform with FluoroGuide 2D and its first in market CT/MRI to Fluoro Registration technology, integrating both preoperative CT and MRI with intraoperative 2D fluoroscopy for advanced 3D navigation.
“Access to advanced spine navigation remains limited worldwide, in part due to the high cost and complexity of intraoperative 3D imaging required by many navigation platforms,” said Ahmad Kolahi, CEO of CKI. “Navient’s CT/MRI to Fluoro Registration is designed to remove this barrier and make navigation more accessible and affordable. It enables hospitals and ambulatory surgery centers, ASCs, to use the conventional 2D C arm they already own while gaining access to advanced 3D navigation, reducing equipment cost and workflow complexity and, more importantly, helping reduce radiation exposure for both patients and operating room staff.”
About Navient
Navient is CKI’s surgical navigation platform for spine, cranial, ENT, and biopsy procedures. Designed around the principles: Intuitive. Precise. Portable., Navient combines advanced optical tracking, imaging integration, registration technologies, and AI assisted surgical planning in a compact and portable platform, making advanced navigation practical and accessible for a broader range of hospitals, ASCs, and outpatient surgical facilities.
About ClaroNav Kolahi Inc.(CKI)
CKI is a Toronto based medical technology company specializing in advanced surgical navigation systems. By combining intelligent, AI powered software with precision engineered hardware, CKI develops next generation solutions that empower surgeons with smarter tools and greater precision to enhance clinical confidence and improve patient outcomes.
Contacts
ClaroNav Kolahi Inc.
Website https://medical.claronav.com/
Email: info@claronav.com
Author
TH
TJ Halvorson
The De Angelis Group | Orthopedics This Week | MSK Innovations
Why This Matters
Two Perspectives
MBA Lens: Economic and industry impact
ClaroNav Kolahi Inc. secured EU MDR certification for its Navient Surgical Navigation System, ensuring continued market access and regulatory compliance across the European Union. This strategic milestone reinforces CKI's global presence and commitment to high standards. The Navient platform's CT/MRI to Fluoro Registration technology aims to democratize advanced 3D navigation by reducing equipment costs and workflow complexity for hospitals and ASCs, potentially expanding market adoption significantly.
- The certification enables CKI to maintain and grow its market share in the EU under the stringent new regulations.
- Navient's cost-effective 3D navigation solution, utilizing existing 2D C-arms, targets broader accessibility and competitive advantage.
PhD Lens: Clinical and outcomes impact
ClaroNav Kolahi Inc.'s Navient Surgical Navigation System achieved EU MDR certification, covering the system and reusable instruments. For spine surgery, the Navient platform now features FluoroGuide 2D and a CT/MRI to Fluoro Registration technology. This innovation integrates preoperative CT/MRI data with intraoperative 2D fluoroscopy for advanced 3D navigation, aiming to reduce radiation exposure for patients and staff by leveraging conventional 2D C-arms.
- The system combines advanced optical tracking, imaging integration, registration technologies, and AI-assisted planning.
- Its design prioritizes intuitiveness, precision, and portability, making advanced navigation practical for various surgical settings.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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