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The Pill Sense System is a prescription only device consisting of a reusable receiver and singleuse ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract in hemodynamically stable adults suspected of having upper gastrointestinal bleeding (UGIB). Pill Sense is not a standalone diagnostic device, but an adjunct for clinical decision making. A negative or normal result obtained by Pill Sense System does not exclude presence of pathology, if symptoms persist, further evaluation should be performed.

The Pill Sense system is designed to detect blood in the upper gastrointestinal tract. The overall system consists of a Pill Sense Capsule and Pill Sense Receiver. The capsule and receiver components are packaged and sold separately or as a system. The capsule is a single-patient use, battery-powered capsule that features sensors that detect blood and wirelessly transmit data to an external receiver. The capsule makes its way through the gastrointestinal tract and is then passed naturally from the body. The reusable receiver collects and displays real-time information gathered by the capsule. The receiver interprets the data and displays a sensor output value. It plots these values on a chart using data acquisition and when completed displays a "blood detected" or "no blood detected" message. The software supports entering of the patient information, pairing of the receiver and capsule and data interpretation and display. Within the ingestible capsule, four lights with distinct wavelengths and a photodetector are located within a sensing well in the center of the capsule. Each light is sequentially pulsed to emit light into the capsule sensing well and based on the liquid in the sensing gap, the emitted light is partially or fully absorbed. The remaining light is received by the photodetector, which converts an electrical signal proportional to the amount of light. Once a "blood detected" message is displayed, it remains on the screen and does not change during the rest of the monitoring. If the monitoring is stopped by the user before 5 minutes has elapsed, an "Inconclusive results" message will be displayed. Only one final readout is given at the end of the 5minute monitoring period, and there is no quantification of blood detected. The overall time from capsule activation, ingestion and display of a reading takes less than 10 minutes. By design, the user is required to monitor for a minimum of 5 minutes and the monitoring automatically stops after 10 minutes. As soon as a "Blood Detected" message is received, the user can stop monitoring at any time. If deemed necessary, the user can continue monitoring for up to 40 minutes.