Abstract
It is estimated that 19 million people in the United States may suffer from diseases related to the small intestine, including obscure bleeding, irritable bowel syndrome, Crohns disease, chronic diarrhea, and cancer. Current diagnostic methods, including push enteroscopy and radiology, produce historically low diagnostic yield. Early studies show that the M2A(TM) Capsule Endoscope effectively visualizes the entire small bowel and demonstrates a 71% superior diagnostic yield when compared to push enteroscopy according to clinical trials reviewed by the FDA. In addition to potentially higher diagnostic yields, it provides a noninvasive diagnostic alternative where none previously existed. The M2A(TM) Capsule Endoscope received FDA clearance in August 2001 and is currently in use at major medical centers throughout the United States and Europe.