Ingestible Capsule Evaluates Patients for Gastroparesis

Gastroparesis is a condition that affects a wide range of patients, including up to an estimated 50% of diabetics and those suffering from Parkinson's disease.

The SmartPill gastrointestinal (GI) monitoring system developed by SmartPill Corp. (Buffalo, NY, USA) has been cleared by the U.S. Food and Drug Administration (FDA), granting the company authorization for the sale and use of the system and the SmartPill pH.p capsule in the United States.

The capsule transits the intestines by peristalsis, the normal rhythmic contraction of the intestinal muscles, and is capable of transmitting data continuously for more than 72 hours. The single-use capsule is excreted naturally from the body, usually within a day or two, without pain or discomfort.

The battery-operated SmartPill contains wireless data receivers and mobile data storage facilities. It is capable of transmitting real-time data to a wireless interface device for monitoring the examination on a standard PC. It also stores a complete record of the data captured by the SmartPill pH.p capsule for download to a personal computer (PC) after the test is completed. The data receiver records pressure, temperature and pH data, elapsed time, and real time for download to a PC after the examination is completed.

The patient may wear the SmartPill data receiver on a belt around the waist or a lanyard around the neck; it may also be set on a table. Patients are free to carry on their other activities during the outpatient exam. At the end of the transit time, the patient returns the SmartPill data receiver to the doctor.

In addition to FDA approval in the United States, SmartPill was recently licensed for use in Canada. Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the country's regulations.



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