Technology | January 05, 2012

NinePoint Receives FDA Clearance for First Volumetric OCT Endoscopic Imaging System

 January 5, 2012 – NinePoint Medical Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Nvision VLE Imaging System, a next-generation, high-resolution optical imaging technology. The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross-sectional and real-time depth visualization.

The Nvision VLE Imaging System is the first volumetric optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging. It uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images simultaneously in real-time. Clinicians can then analyze and immediately act on these images, thus providing patients with streamlined care and a significantly shortened timeline between detection, diagnosis and treatment.

The Nvision VLE Imaging System:

  • Is the only technology that can generate a volumetric image of the target organ in real-time that can be viewed simultaneously in cross-section and longitudinal vizualization.
  • Utilizes a high-resolution display and proprietary software to provide an image that can be reviewed to identify areas of suspicion such as inflammatory, metaplastic or dysplastic changes, or possible cancers.
  • Can image beneath the mucosal surface at less than 10 micron resolution up to a tissue depth of 3 mm, unlike white light endoscopy, which can only image surface detail. This also compares favorably to confocal microscopy, which only has up to 250-500 microns depth of penetration.
  • Offers a full field, circumferential view, compared with confocal microscopy, which only offers a 0.5 x 0.5 mm segment of tissue view.
  • Can image circumferentially or helically up to 6cm in length in less than 100 seconds.  

“We will be conducting clinical trials of the Nvision VLE Imaging System in 2012 and will be scaling up our manufacturing capabilities to support a commercial launch in 2013,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical.  “We believe our technology can improve patient outcomes, shorten the timeframes associated with diagnostic and treatment procedures and significantly reduce health care system costs.”

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

For more information:


Related Content

CapsoVision Inc. Introduces CapsoCloud for CapsoCam Plus Endoscopy System
Technology | Endoscopes | September 14, 2017
CapsoVision Inc. recently announced the full U.S. launch of CapsoCloud, an exam management system that allows...
Pentax Medical Launches New Slim Linear Ultrasound Endoscope
Technology | Endoscopes | August 17, 2017
Pentax Medical Co. announced the U.S. launch of the Slim Linear Ultrasound Endoscope (EG-3270UK), the company's newest...
Fujifilm Issues Voluntary Recall of All ED-530XT Duodenoscopes
News | Endoscopes | August 03, 2017
August 3, 2017 — On July 21, 2017, Fujifilm issued an Urgent Medical Device Correction and Removal notification infor
Feature | Endoscopes | February 01, 2017 | Ravi Chawat
Several diseases that require the use of endoscopy devices for diagnostics, as well as therapeutics, have been on the
News | Endoscopes | January 16, 2017
January 16, 2017 — Fujifilm Medical Systems has informed the U.S.
Given, Pillcamp, colonoscopy, Angiodysplasias, capsule Endoscopy, LVAD interference

The Given Imaging PillCam Colon system is an example of a capsule endoscopy device the patient swallows to image the gastrointestinal track.

Feature | Endoscopes | January 03, 2017 | Anamika Kumari
The capsule endoscopy systems offer a hands-free and highly accurate imaging modality for healthcare practitioners.
Olympus, Visera 4K UHD System, operative display, endoscopy, ultra-high definition
Technology | Flat Panel Displays | September 15, 2016
Olympus announced that big-screen surgery with 4K UHD (ultra-high definition) endoscopy is now available for ear, nose...
Pentax Medical, Defina endoscope system for Pulmonology, EMEA market
Technology | Endoscopes | July 05, 2016
Pentax Medical announced the launch of a new high-definition (HD) pulmonology endoscopy system in the European, Middle...
Avantis Medical Systems, Third Eye Panoramic colonoscopy device, endoscopes, FDA, resposable

From left to right: (1) Panoramic device’s left-viewing camera, (2) Colonoscope’s forward-viewing camera, (3) Panoramic device’s right-viewing camera. The adenoma seen in this image was hidden from the colonoscope’s view but was detected with the Third Eye Panoramic.

Technology | Colonoscopy Systems | May 23, 2016
Avantis Medical Systems Inc. announced that it has received 510(k) clearance from the U.S. Food & Drug...
Integrated Endoscopy, nuvis single-use arthroscope, AAOS 2016
News | Endoscopes | March 22, 2016
March 22, 2016 — Integrated Endoscopy Inc.
Overlay Init