NinePoint Medical OCT imaging system garners FDA clearance

NinePoint Medical (Cambridge, MA) has received FDA 510(k) clearance to market its Nvision VLE volumetric optical coherence tomography (OCT) device for endoscopic imaging. The device is the first of its kind to use a circumferential scanning technique and an automatic pullback to generate cross-sectional and longitudinal images simultaneously in real time.

The system's high-resolution display and proprietary software provide images that can be reviewed by a physician to identify areas of suspicion, such as inflammatory, metaplastic, or dysplastic changes, or possible cancers. It can image beneath the mucosal surface at <10 µm resolution up to a tissue depth of 3 mm; offers a full-field, circumferential view; and can image circumferentially or helically up to 6 cm in length in <100 s.

The company will be conducting clinical trials of the system this year and will be scaling up its manufacturing capabilities to support a commercial launch in 2013, says Charles Carignan, M.D., president and CEO of NinePoint Medical. Additional features for the system are in the works as well, he say.

In 2010, the company entered into an intellectual property licensing agreement with Massachusetts General Hospital (MGH) supporting the development of the system. Under the agreement, NinePoint obtained certain exclusive rights in multiple fields to 188 patents and patent applications owned by MGH.

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