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.
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