FDA Clears NinePoint Medical Nvision VLE Imaging System

NinePoint Medical received FDA 510(k) clearance for its Nvision VLE Imaging System, a high-resolution optical imaging technology for use as an imaging tool in the evaluation of human tissue microstructure, according to a news release.

The device provides two-dimensional, cross sectional and real-time depth visualization. The system is also the first FDA-cleared volumetric optical coherence tomography for endoscopic imaging using a circumferential scanning technique and an automatic pullback.

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