ABOUT CLARONAV

ClaroNav is dedicated to the development of surgical navigation solutions. We were founded in 2001 as Claron Technology Inc. by Claudio Gatti and Doron Dekel (hence the name), both having a long and rich experience in developing sophisticated medical 3D visualization and surgical navigation systems. Unlike most high-tech medical device start-ups that seek VC or angel funding, the founders bootstrapped the company using its own profits. The company’s founders and employees own over 90% of its shares.

Claron Technology experienced rapid growth since 2005, expanding the range of technologies and capabilities it offers while diversifying its customer base. Based on its 5-year revenue growth, it was recognized 4 times by Profit Magazine as one of Canada’s 500 fastest growing companies.

In January 2015, the non-navigation divisions of the company were acquired by Lexmark Inc.. We subsequently renamed the company ClaroNav.

Our surgical navigation roots go back to the development of the first commercial CT-based navigation system, the Viewing Wand, which our founders developed while at ISG Technologies (now part of IBM). The Viewing Wand, FDA cleared in 1994, was used to guide neurosurgery. After we left ISG and formed our own company, we developed and marketed the first vision-based optical tracking system for surgery, the MicronTracker (2003). We then helped other companies develop their own complete MicronTracker-based surgical navigation systems, and, starting in 2010, we initiated our own. We worked closely with dental surgeons to develop and market Navident (first regulatory approval in 2014), and with ENT surgeons to develop and market NaviENT (first approval in 2016).

We currently develop, test, manufacture, market, sell, train, and support our products at our Toronto headquarters. We also market, train and support out of our offices in Europe and East Asia, as well as through a network of national distributors.

ClaroNav is proud to report that it has achieved and maintains compliance with regulatory requirements throughout the world. Our products are designed and manufactured under our ISO 13485:2016 and FDA-compliant Quality Management System and our products are certified to all applicable standards. Please see the list below for our international registrations.

QUALITY MANAGEMENT SYSTEM

ISO 13485 quality system certification (PDF format)

ISO 13485:2016 MDSAP Certificate (ClaroNav)  EN ISO 13485:2016 Certificate (ClaroNav)  ISO 13485:2016 MDSAP Certificate  (ClaroNav Kolahi Inc.)

US FDA Good Manufacturing Practice (GMP) 

We are fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website 

PRODUCT CERTIFICATIONS AND APPROVALS

AUSTRALIA – Devices listed in ARTG 

Navident 

CANADA – Medical Device Licenses 

Navident | Navient ENT | Navient Cranial

CHINA – NMPA

Navient

ECUADOR

Navient

EUROPE – CE Marking certificates (PDF format)

Navident | Navient

EUROPE – Declarations of Conformity (PDF format)

Navident | MicronTracker | Navient

IRAQ

Navient

MEXICO

Navident

KOREA – MFDS

Navient

SIR LANKA

Navient

SYRIA

Navient

TAIWAN – FDA

Navident | Navient

THAILAND

Navident | Navient

UNITED ARAB EMIRATES – MOH classification certificate 

Navident | Navient

UNITED STATES – FDA 510(k) cleared devices 

Navident | Navient

GLOBAL REGULATORY REPRESENTATIVES

Shown below are in-country regulatory representatives for issues and incident reporting. 

AUSTRALIA – Sponsor Representative

Emergo Australia, Sydney, Australia

Telephone: +61.2.9006.1662

EUROPE – Authorized Representative

Emergo Europe, The Hague, Netherlands

Telephone: +31.70.345.8570