SmartPill Wins 510(k) Release From FDA
BUFFALO, N.Y., July 20 /PRNewswire/ -- SmartPill Corp., a leading developer of capsule-based medical devices based in Buffalo, N.Y., is proud to announce today that its SmartPill GI Monitoring System has received 510(k) release from the federal Food and Drug Administration, granting the company a "green light" for the sale and use of its SmartPill GI Monitoring System and SmartPill pH.p Capsule in the United States.
"This is what the entire SmartPill team has been working for, ever since our company was founded in 2003," said David Barthel, President and CEO of The SmartPill Corporation. "Our goal all along has been to provide gastrointestinal (GI) professionals with a new, less invasive, cutting-edge medical device for patient evaluation. With 510(k) release, SmartPill can now begin actively marketing and selling our products to GI professionals and, in turn, help patients throughout the U.S."
"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 Dr. Braden Kuo, chairman of SmartPill's scientific advisory board and an instructor at Harvard Medical School and Assistant in Medicine, Department of Internal Medicine, 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."
Slow gastric emptying, or gastroparesis, is a condition that affects a wide range of patients, including up to an estimated 50 percent of diabetics and those suffering from Parkinson's disease. With the SmartPill GI Monitoring System, GI professionals can now better evaluate patients for gastroparesis, which many agree has been underdiagnosed in patients for years.
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 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. The patient then returns to the doctor, who downloads the information from the SmartPill Data Receiver.
In addition to the Capsule and the Receiver, the SmartPill GI Monitoring System also includes the SmartPill Data Receiver Docking Station, and SmartPill Software.
In addition to FDA approval in the U.S., SmartPill was recently licensed for use in Canada. SmartPill received its medical device license on June 22 from Health Canada's Medical Devices Bureau, Therapeutic Products Directorate. Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with that country's regulations.
About SmartPill Corp.
The SmartPill Corporation is a leading 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 pH.p Capsule, an ingestible medical device that provides data, heretofore unavailable, that can assist physicians and researchers in the evaluation of GI motility disorders. SmartPill Corporation's SmartPill GI Monitoring System was approved for sale and use in Canada in June 2006 and was granted 510(k) release from the U.S. Food and Drug Administration (FDA) in July 2006. The System will be available for sale in the U.S. and Canada in the fall. Visit www.SmartPillCorp.com for more information.
The SmartPill CorporationCONTACT: Leslie A. Hornung, Vice President of Marketing, The SmartPillCorporation, 1-800-644-4162 Ext. 111, +1-716-380-2599 cell,lhornung@smartpillcorp.com; Megan Connor Murphy, Public Relations Manager,Dixon Schwabl Advertising, +1-585-899-3258, +1-585-613-6679 cell,megan@dixonschwabl.com
Web site: http://www.SmartPillCorp.com/