Endoscopic imaging pill gets FDA clearance

Given Imaging of Israel has received Food and Drug Administration clearance for an ingestible pill capable of producing endoscopic images of the small intestine as it travels through the body.

Given's M2A Capsule is a single-use pill with color video recording capability that is ingested, collects images as it moves through the digestive tract, and is then naturally excreted. A belt worn around the patient's waist receives signals transmitted by the capsule, which are then processed on a workstation and converted into video.

In a recent clinical trial, the pill detected physical abnormalities in 12 of 20 patients, while push enteroscopy detected physical abnormalities in 7 of 20 patients, or 35%. The pill was able to identify sources of bleeding in five cases that were beyond the reach of the traditional enteroscope, the company said.

In other news, Given plans to issue an initial public offering in U.S., the company said yesterday. The company intends to complete the IPO in the second half of this year.

By AuntMinnie.com staff writers
August 3, 2001

Copyright © 2001 AuntMinnie.com

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