NinePoint Medical said today that it won 510(k) clearance from the FDA for a real-time targeting feature on its flagship NvisionVLE gastrointestinal imaging device.
NvisionVLE uses optical coherence tomography to perform what it calls volumetric laser endomicroscopy to produce real-time, high-resolution cross-sectional images of the GI tract. The new targeting feature, enabling doctors to locate and mark areas of interest, was used for the 1st time in procedures at Boston’s Beth Israel Deaconess Medical Center, Bedford, Mass.-based NinePoint said.
“Today’s announcement represents the successful culmination of a 4-year effort by the NinePoint Medical team and our advisors to bring this significant targeting feature for our OCT-based imaging platform to the U.S. market,” president & CEO Christopher von Jako said in prepared remarks. “We are currently conducting a controlled-market release at a few select U.S. hospitals, and look forward to making the feature more broadly available to our customers later in 2016.”
“OCT imaging has become an integral part of the care of my patients with esophageal disease,” added Beth Israel’s Dr. Douglas Pleskow. “The addition of real-time targeting will streamline the procedure and provide me with more confidence when targeting esophageal tissue for biopsy or treatment.”
Last November, NinePoint reported a funding round worth $30.7 million, saying it hoped to raise a total of $40.7 million.