FDA approves digestible chips in pills

  On August 3, 2012, the U.S. Food and Drug Administration (FDA) approved the use of the first absorbable sensor. The Ingestion Event Marker (IEM), manufactured by Proteus Health, represents a new class of medical device: the instrument is composed entirely of food components and is activated during digestion.  ”The FDA’s confirmation (of this device) is a huge milestone in digital medicine. For the first time, a digital pill is directly combined with a wireless base component, which could lead to the emergence of new standards that are sufficient to influence compliance with medical drug therapy and clearly contribute to the management of chronic diseases.” So said Eric Topol (MD), professor of genomics at the Scripps Research Institute in La Jolla, California, in a company press release. dr. Topol is the author of the book “The Creative Destruction of Medicine: How the Digital Revolution is Optimizing Health Care”.  The sensor, which is the size of a grain of sand, is made primarily of elemental silicon, and it can be built into the interior of inactive pills or externalized to other absorbable objects (such as pharmaceutical preparations.) The Proteus Digital Health Feedback System integrates externalized and ingestible sensor technologies to produce an instrument that can detect drug absorption and physiological profiles.  A single-use patch is applied to the body in order to collect and record data on physiological responses and stimulus responses obtained from the body. In addition to recording the information obtained from the sensors, the patch can record data on heart rate, body temperature, body activity or rest patterns. The patch can continue to work for about 7 days, it is powered by a battery that can also last for about 7 days.  The display device can then be carried around in a garment pocket or small bag to display the contents of the data and for maintenance support. Using the sensor, it is possible to detect the exact time of taking the medication, as well as the unique characteristics of the medication. This information is controlled by the patient’s body itself.  The IEM does not contain a battery. The IEM is the only instrument that is powered by the body to drive the ingestibility sensor. The sensor passes through the body (the gastrointestinal tract) similar to cellulose.  The system, customarily known as the Raisin System, was approved by the European regulatory authorities in August 2010. The technology has been used in clinical trials on patients for thousands of days without serious adverse events. Proteus Digital Health does not price the device, but states on their website, “Costs are dependent on what is being tested with the system.”