SmartPill Announces 510(k) Release for Evaluation of Constipation
Physicians Have New Method for Evaluating GI Motility Disorder
Nov 06, 2009
Buffalo, NY – SmartPill Corporation announced today the recent U.S. Food and Drug Administration (FDA) 510(k) release of the SmartPill GI Monitoring System, version 2.0, for the evaluation of colonic transit time in patients with suspected chronic constipation. The new 510(k) release was an expansion of SmartPill's previous indication for use in evaluating patients with suspected delayed gastric emptying (gastroparesis).
"This is a significant milestone for the Company," remarks David Barthel, President and CEO of the SmartPill Corporation. "The new indication expands the market capabilities of SmartPill, allowing the device to evaluate an additional disease (chronic constipation) and more importantly, enhances our objective of improving patient care."
The SmartPill GI Monitoring System, version 2.0, allows physicians to measure pH, pressure and temperature throughout the entire gastrointestinal (GI) tract, providing whole gut and regional gut (gastric, small bowel and colonic) transit times, a pH profile of the entire GI tract and GI tract pressure patterns. SmartPill's ability to differentiate slow (abnormal) transit from normal transit, while providing regional transit times for both the upper and lower GI tract, is an important assessment for physicians when evaluating GI motility disorders and guiding appropriate therapy.
"SmartPill's recent validation study has proved it to be a reliable, ambulatory and standardized technique for measuring transit throughout the entire GI tract," comments Dr. Satish Rao, a distinguished clinician in neurogastroenterology and GI motility, from the University of Iowa. "For clinical purposes, SmartPill provides a single test that comprehensively assesses regional transit times and reduces the duration of colon transit study, thereby improving patient compliance and providing physicians with better direction for managing their patients."
The SmartPill GI Monitoring System features the SmartPill Capsule, a wireless, ingestible medical device about the size of a large vitamin pill. The patient ingests the single-use SmartPill Capsule in the doctor's office and then returns to their daily activities. As the Capsule travels through the GI tract, data is wirelessly transmitted to the SmartPill Data Receiver. The SmartPill Data Receiver is later returned to the physician's office where the data is downloaded to a computer providing gastric, small bowel, large bowel, and whole gut transit times.
The SmartPill GI Monitoring System, version 2.0, will be available for shipment in January 2010.
About SmartPill Corporation
SmartPill Corporation is a leading manufacturer and developer of capsule-based medical devices that aid in the diagnosis, definition and therapeutic intervention of gastrointestinal (GI) motility disorders and diseases. The company's flagship product – the SmartPill GI Monitoring System – features the SmartPill Capsule, an ingestible medical device that provides data, heretofore unavailable, that can assist physicians in the evaluation of gastroparesis and chronic constipation. The SmartPill GI Monitoring System was granted initial 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006 and for the evaluation of colonic transit in October 2009. Dr. Satish Rao serves as a scientific advisory board member to the SmartPill Corporation. Visit www.SmartPillCorp.com for more information.