The FDA has given the go ahead to SmartPill (Buffalo, NY) to market version 2 of the firm’s device for evaluation of constipation. The device measures temperature and pH as it moves through the GI tract, and provides temporal-spacial analysis of its voyage. The system was already approved for analysis of suspected delayed gastric emptying (gastroparesis).
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.
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.
Press release: SmartPill Announces 510(k) Release for Evaluation of Constipation …
Product page: SmartPill GI Monitoring System …
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