TEL AVIV, July 15 (Reuters) - 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 conduct.
“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.”