SmartPill Corp., a developer of capsule-based medical devices, announced today that its SmartPill GI Monitoring System has received 510(k) release from the FDA for the sale and use of the gastrointestinal monitoring system in the United States.
“FDA approval means GI professionals who treat patients with slow gastric emptying now have a new alternative when it comes to diagnosing their patients,” said Braden Kuo, MD, PhD, chairman of SmartPill’s scientific advisory board and an instructor at Harvard Medical School and Assistant in Medicine, Department of Internal Medicine at Massachusetts General Hospital. “GI professionals no longer need to rely on what has been the traditional, and often inaccurate, test methodology. With the availability of SmartPill, new doors will be opened for those who treat patients with underdiagnosed motility disorders, giving them the opportunity to collect data and measure transit time – in a way that’s never been done before.”
The SmartPill pH.p Capsule is a wireless, ingestible medical device – about the size of a large vitamin pill – that measures pressure and pH, gastric emptying time, combined small and large bowel transit time, and total transit time, the company said.
The Capsule travels through the gastrointestinal tract, collecting and transmitting data to the SmartPill Data Receiver. The Receiver, slightly larger than a cell phone, is worn on a patient’s belt or around the neck on a lanyard.
Patients can take the test right in their physicians’ offices. A patient ingests the single-use SmartPill pH.p Capsule in the doctor’s office and, within a day or two, the disposable capsule is excreted naturally from the body and retained. The patient then returns to the doctor, who downloads the information from the SmartPill Data Receiver, the company said.
In addition to FDA approval in the U.S., SmartPill was recently licensed for use in Canada.