The FDA recently greenlit an Irish devicemaker’s request to market its Pill Sense System, an ingestible capsule that winds its way through a patient’s gastrointestinal tract, detects light wavelengths and wirelessly transmits data.
EnteraSense’s product, which is single-use and prescription-only, is engineered to detect blood in patients “suspected of having upper gastrointestinal bleeding,” the FDA said Feb. 24. It is not a standalone treatment but is intended to be used among other clinical decision-making devices.
The Pill Sense System consists of a reusable receiver and a single-use ingestible capsule that resembles a clear battery.
