FTL Labs Corporation SBIR Phase II Award,

This project develops an ultrasonic fitment tool to improve prosthetics performance for persons with lower-extremity amputations. The goal of this project is to develop a new clinical instrument used in the socket fitting process to optimize the performance of a lower-body prosthetic system and thereby improve mobility, activity, exercise, and quality of life for over 2 million American amputees. The ultrasonic device, called “SoundFit” uses low-cost, line-of-sight ultrasound transducers and a novel signal reconstruction and visualization system to elucidate the residual degrees-of-freedom of the bone inside a patient’s residual limb as socket fit modifications are made. This data represents a critical knowledge gap, and current practices are non-quantitative, difficult to train and reproduce, and vary widely between prosthetist shops. The specific objectives of the Phase II program are: (1) research and refine the electronics hardware and software system demonstrated in Phase I; (2) create novel wavelet signal processing algorithms to improve performance in challenging residual limb tissue; (3) perform clinical efficacy testing demonstrating the value of the technology; and (4) develop all testing and documentation necessary for FDA 510(k) submission.