Date: Sep 18, 2012 Source: (
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Hillsborough, NC (September 18, 2012)--The Food and Drug Administration has approved InnerOptic's AIM System to be sold in the United States. AIM received 510(k) clearance for guiding an interventional needle and for predicting its future path on a stereoscopic monitor. Surgeons, interventional radiologists and other physicians can use AIM for any needle-based intervention using ultrasound, such as biopsies or tumor ablations.
AIM is a "GPS" for needle-based interventions. It provides 3D visualization and guidance for ultrasound-assisted open, percutaneous and laparoscopic biopsies and ablations. Like a GPS, AIM continually monitors the 3D positions of the needle and ultrasound transducer, and provides the physician with an intuitive stereoscopic view of their spatial relationship in real time. A published study in a peer-reviewed medical journal established that using AIM results in easier, faster and more accurate needle interventions. The AIM software uses electromagnetic tracking to continually monitor the position and orientation of the needle and of the ultrasound transducer, displaying 3D avatars of them in real-time via an intuitive user interface on a stereoscopic monitor.
To date, AIM has been integrated with ultrasound scanners from BK Medical and Aloka and devices from Halt Medical and Microsulis. Halt uses AIM for Guidance AIM displays the 3D virtual needle, virtual ablation "cage" and needle trajectory for Halt Medical's radiofrequency ablation device. AIM has been used in an IRB-approved clinical trial at the Carolinas Medical Center to validate its clinical effectiveness for hepatic tumor ablation. Dr. John Martinie presented preliminary results of this trial at the Annual Meeting of the American Hepato-Pancreato-Biliary Association (AHPBA) in March 2012. "We are pleased to have received FDA clearance for AIM, with such a broad indication for use" said Brian Heaney, InnerOptic's CEO. "We look forward to working with our customers in the release of AIM-guided products."
About InnerOptic Technology, Inc.
InnerOptic was founded in 2003 to commercialize the patented medical visualization technology developed by researchers at the University of North Carolina at Chapel Hill. InnerOptic is revolutionizing image-guided procedures with its InnerOptic's AIMâ„¢, a "GPS" that improves a physician's ability to accurately perform complex minimally invasive procedures with ultrasound imaging. A privately held company, InnerOptic is head quartered in Hillsborough, NC. For more information, please visit http://www.inneroptic.com