The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel electromagnetic navigation system offering a transformative solution for a wide range of medical procedures that demand accuracy, efficiency, and safety. The result of this capability and its subsequent commercialization will positively affect the outcomes of medical procedures for millions of patients worldwide. The system will enable tracking medical instruments over the full procedure space, improving accuracy and reliability, and reducing patients and staff exposure to harmful radiation while being compatible with the intraoperative imaging. The device will allow for the creation and augmentation of navigation volumes on demand during procedures as well as reliable detection and mitigation of electromagnetic interference. The broader societal impacts of the technology offer a flexible and highly customizable platform across key industry sectors important to the United States competitiveness including biomedical, consumer, industry, and defense. This Small Business Innovation Research (SBIR) Phase II project will advance the development of a new electromagnetic navigation system that requires the solution of several complex problems involving mathematics, computer science and electrical engineering. Millions of minimally invasive medical procedures are performed annually worldwide which include cardiac ablations, valve replacements, bronchoscopies, orthopedic procedures, cancer treatments, etc., all with increasing robot utilization. Electromagnetic navigation systems are widely used in these procedures providing knowledge of locations and orientations when medical instruments are out of the ?line of sight?. Currently available systems, mostly developed before the wide adoption of robotic surgeries, can handle only fixed navigation volumes and are often unable to track instruments throughout the full procedure space, which may require the use of additional harmful X-ray radiation. Current tools use bulky field generators incompatible with imaging equipment and provide only limited detection and correction of electromagnetic interference-induced location distortion. This project will address these shortcomings. The electromagnetic navigation system which will have robust detection and mitigation of various electromagnetic interferences, will enable procedure-time adjustable navigation volumes, will allow high location sampling rates with multiple sensors, and will be compatible with intraoperative fluoroscopy and computed tomography (CT) imaging, allowing for key differentiating features required for commercialization.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
