SmartPill

SmartPill Corporation, founded in Buffalo, NY, in 2000 by David Barthel, developed a capsule-based medical device for diagnosing gastrointestinal (GI) motility disorders. An early version of the technology was co-developed by Jerome J. Schentag and David D'Andrea in 1992. Barthel, with a background in life sciences and technology sales, led the company from a ground-zero startup to a significant player in the biotech space.

The company's key product, the SmartPill GI Monitoring System, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in July 2006 for evaluating patients with suspected delayed gastric emptying, also known as gastroparesis. This was a significant milestone, allowing the company to market and sell its system to gastroenterology professionals across the United States and Canada. In 2012, The SmartPill Corporation was acquired by Given Imaging, an Israeli company known for its PillCam endoscopy devices, for $6 million. This acquisition was part of Given Imaging's strategy to expand its portfolio in functional GI diagnostics. Subsequently, in 2015, Medtronic purchased Given Imaging, bringing the SmartPill technology under its umbrella.

The SmartPill is an ingestible, single-use capsule, approximately the size of a large vitamin, that a patient swallows in a clinical setting. It is designed to measure pressure, pH, temperature, and transit time as it moves through the entire digestive tract—stomach, small bowel, and colon. This data is wirelessly transmitted to an external recorder worn by the patient. Physicians can then download and analyze this information to assess GI motility, helping to diagnose conditions like gastroparesis and chronic constipation without radiation exposure. The system provides a complete transit profile from a single test, offering a less invasive alternative to procedures like gastric emptying scintigraphy and radio opaque markers. However, as of June 2023, Medtronic announced the discontinuation of the SmartPill due to challenges in sourcing specialized components required for its manufacture.

Keywords: GI motility, gastroparesis, chronic constipation, ingestible sensor, wireless motility capsule, medical device, gastroenterology, diagnostic tool, transit time, pH monitoring, pressure monitoring, Medtronic, Given Imaging, digestive health, non-invasive diagnostic, capsule-based device, gastrointestinal disorders, GI tract monitoring, gut transit, motility testing