Proteus (News - Alert) Biomedical recently announced European Union approval of its ingestible sensor and personal physiologic monitor system. The sensors are designed to be safe to swallow in order to communicate physiological data from inside the body to computerized devices such as mobile phones.
The CE Mark certifies that the Raisin system meets EU consumer and health requirements. In addition to the CE Mark, Proteus announced that it received ISO 13485:2003 certification for the design, development and manufacture of its product system. The personal monitor, an adhesive patch, received FDA 510(k) clearance earlier this year.
As described on the Proteus website, ingestible event markers (IEMs) are “tiny, digestible sensors made from food ingredients, which are activated by stomach fluids after swallowing.” After they are activated, IEM’s create an “ultra-low-power, private, digital signal” that can be detected by a microelectronic recorder. The system is able to timestamp the ingestion of a specific pharmaceutical or other discrete events, and to record these events along with physiological data such as heart rate, activity, body angle and other patient-logged information.
Proteus has developed the Raisin system as part of an effort to create integrated product systems aimed at diabetes, cardiovascular disease, psychiatric disorders, organ transplantation and infectious disease. (Press release via BusinessWire; for more information on the ingestible sensor system, please see our earlier coverage of the Proteus Raisin).Ms. Graham is a writer and editor with a current focus on health and wellness. To read more of her articles, please visit her columnist page.
Edited by Erin Monda