TEL AVIV, July 15 Israeli camera-in-a-pill maker
Given Imaging has received Japanese regulatory
approval for its PillCam Colon video capsule for diagnosis of
colonic disease when colonoscopy is required but difficult to
"The clearance of PillCam Colon in Japan, the world's second
largest healthcare market, represents an important
accomplishment for Given Imaging," the company's chief
executive, Homi Shamir, said on Monday.
The decision by Japan's Pharmaceuticals & Medical Devices
Agency could expand Given Imaging's potential customer base in
Japan from about 1,000 physicians to as much as 10,000 and will
help in enhancing adherence to screening guidelines for over one
million potential patients, he said.
PillCam Colon is designed to be ingested by the patient and
transmit up to 35 frames per second for approximately 10 hours
to a recording device worn by the patient.
"Meaningful sales of PillCam Colon capsule will commence
immediately after obtaining reimbursement," Shamir said.
Reimbursement in Japan is expected to become effective
during the first half of 2014. PillCam Colon is commercially
available throughout Europe, Latin America, Canada and parts of
Asia. It is pending U.S. Food and Drug Administration clearance.
"The number of deaths due to colorectal cancer in Japan
continues to increase at an alarming rate," said Akira Terano,
president of the Japanese Association for Capsule Endoscopy.
"PillCam Colon is a less invasive medical device which would be
able to drive higher compliance."