NinePoint Medical earns CE Mark approval, ISO certification for OCT system

NinePoint Medical (Cambridge, MA) has garnered European CE mark approval for its NvisionVLE optical coherence tomography (OCT) imaging system for optical endomicroscopy of mucosa and submucosa diseases. The company has also received ISO 13485:2003 certification, an international standard governing the requirements of a quality management system for medical devices and related services, for its Cambridge facility. 

The ISO certification and CE mark approval, falling on the heels of its FDA 510(k) clearance to evaluate human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization, should enable the company to commercially launch the system in 2013, says Charles Carignan, MD, NinePoint Medical's president and CEO. 

The company also began a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus, a common precursor to esophageal cancer, using the system. With the CE Mark, the company will now add two sites in Europe to the clinical trial. 

-----

Follow us on Twitter, 'like' us on Facebook, and join our group on LinkedIn

Follow sister publication Laser Focus World on your iPhone or Android

Subscribe now to BioOptics World magazine; it's free!

Get All the BioOptics World News Delivered to Your Inbox

Subscribe to BioOptics World Magazine or email newsletter today at no cost and receive the latest news and information.

 Subscribe Now
Related Articles

Avinger signs agreement with HealthTrust for OCT image-guided atherectomy system

HealthTrust will acquire Avinger's Pantheris OCT image-guided atherectomy system that recently received FDA approval.

SalutarisMD to introduce minimally invasive ophthalmic device for wet AMD therapy

SalutarisMD has developed an investigational ophthalmic treatment for wet age-related macular degeneration (AMD).

Wearable light therapy device for hair loss receives regulatory approval in Brazil

The iGrow hair growth system, a wearable low-level light therapy device for treating hair loss, is cleared for use in Brazil.

FDA authorizes emergency use of Zika virus molecular detection assay

The xMAP MultiFLEX Zika RNA assay combines optofluidics and digital signal processing to detect Zika virus in vitro.

BLOGS

Neuro15 exhibitors meet exacting demands: Part 2

Increasingly, neuroscientists are working with researchers in disciplines such as chemistry and p...

Why be free?

A successful career contributed to keeping OpticalRayTracer—an optical design software program—fr...

LASER Munich 2015 is bio-bent

LASER World of Photonics 2015 included the European Conferences on Biomedical Optics among its si...

White Papers

Understanding Optical Filters

Optical filters can be used to attenuate or enhance an image, transmit or reflect specific wavele...

How can I find the right digital camera for my microscopy application?

Nowadays, image processing is found in a wide range of optical microscopy applications. Examples ...

CONNECT WITH US

            

Twitter- BioOptics World

Copyright © 2007-2016. PennWell Corporation, Tulsa, OK. All Rights Reserved.PRIVACY POLICY | TERMS AND CONDITIONS