NinePoint Medical announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its high-resolution optical coherence tomography (OCT) technology.
The firm's Nvision VLE system is intended for use in evaluating human tissue microstructure. It provides 2D cross-sectional real-time depth visualization and is designed for endoscopic imaging. It uses a circumferential scanning technique and an automatic pullback to generate cross-sectional and longitudinal images simultaneously in real-time, according to NinePoint.
In 2010, NinePoint entered into an intellectual property licensing agreement with Massachusetts General Hospital supporting the development of Nvision VLE. Under the agreement, NinePoint obtained certain exclusive rights in multiple fields to 188 patents and patent applications owned by the hospital.
NinePoint plans to conduct clinical trials of Nvision VLE this year and will scale up manufacturing capabilities to support a commercial launch in 2013, the firm said.
