The PillSense Capsule (11x27mm) is a single patient use device which features an optical sensor which detects blood and wirelessly transmits data to the battery powered PillSense Receiver. The optical sensor contained in the PillSense Capsule detects the presence of liquid blood and/or hematin by analyzing the absorption of multiple wavelengths of light of the environment in which it is immersed. The data are then processed by an algorithm to determine if blood is present. The PillSense System has been validated to detect clinically relevant amounts of blood to as low as 5% blood in gastric contents. The capsule is designed to withstand the mechanical forces and chemical environment of the digestive system. After ingestion, the PillSense Capsule will make its way through the GI tract and is then passed naturally from the body.
A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.