FDA approves Hillsborough firm’s ‘GPS’ device for surgeons
Dr. John Iannitti uses the InVision System to place an ablation needle into a liver tumor during a recent clinical trail. (InnerOptic photo)
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HILLSBOROUGH, N.C. – Startup InnerOptic’s “GPS” devices for surgeons are headed for the healthcare industry marketplace.
The U.S. Food and Drug Administration has approved InnerOptic’s Invision System for marketing in the U.S., the company said Thursday.
InnerOptic has called Invision a GPS, or global positioning system, for surgeons since the device is designed to guide needs and predict its future path based on a patented 3D visualization system.
Invision is designed for needle-based procedures that use ultrasound, including biopsies.
“The InVision System enables physicians to more quickly and accurately guide a needle into a target on an ultrasound image,” said Dr. John Martinie, a surgeon at the Carolinas Medical Center in Charlotte. He had used the device in a clinical study.
“All practitioners, from novice to expert, will benefit from its 3D guidance,” Martinie said in a statement issued by InnerOptic. Carolinas Medical Center has been working with InnerOptic on the device.
InVision is designed to enable surgeons to make procedures more accurately, more easily and faster.
Citing a clinical study, InnerOptic said the device improved needle placement accuracy by between 35 percent and 88 percent.
In July, InnerOptic received a $99,462 Small Business Innovation Research grant from the National Institutes of Health for applications of its visualization technology. Over a two-month period, InnerOptic received two SBIR grants and matching funds from the state of North Carolina that totaled more than $300,000.
InnerOptic, founded in 2003, is commercializing technology developed at UNC-Chapel Hill.
In December 2007, CatoBioVentures agreed to invest as much as $270,000 in InnerOptic and an unidentified angel investor added another $100,000.
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