Field Programmable Gate Arrays (FPGAs) have dramatically changed the design of medical devices in the past decade. FPGAs offer the flexibility of writing software on a standard microprocessor and the reliability and performance of dedicated hardware. In the design of medical devices that previously required the rigorous design of custom circuits or ASIC design, FPGAs are providing a good alternative at a much lower cost for low to mid-volume medical device design. In this session, we will explore how FPGAs relate to medical device technology including real-time processing of data, high performance image processing, precise control, and code reuse from prototype to deployed device. We will explore how this technology was applied to two devices that improve the success of high-risk surgeries. In the first, FPGA technology is used to monitor blood glucose levels in patients during open-heart surgery. The second example is a device that simulates electrical signals from the human nervous system to train neurophysiologists for events that may happen during surgery. We will explore the impact FPGAs have on design cycles, briefly explore the design process, and compare different programming methodologies including C, VHDL, and LabVIEW. Finally, we will discuss the impact of FPGAs with respect to the 510k process.

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