As reported in Bloomberg: Given Imaging, the Israeli company with a very strong presence in Australia has been approved in the Japanese market.
Given Imaging Ltd. said Monday that regulators in Japan have approved its PillCam pill-sized diagnostic camera for use in diagnosing diseases of the colon.
The Israeli company said the PillCam Colon is approved for diagnosing disease when a colonoscopy is required but the patient is unwilling or unable to have a colonoscopy. The PillCam is capsule-sized and contains two small cameras that can transmit data for about 10 hours. The data is captured by a recording device worn by the patient.
Given Imaging said it expects government reimbursement for PillCam to begin in early 2014, and said “meaningful” sales should begin around that time.
Its shares rose 96 cents, or 6.8 percent, to $14.99 in morning trading.
The company said Japanese guidelines call for everyone to over the age of 40 to have a fecal occult blood test, a type of test used to detect colon cancer. Given Imaging said about 25 percent of people actually get tested. When patients are advised to get a colonoscopy following the blood test, almost half of them do not have the colonoscopy. Given Imaging said PillCam Colon could appeal to patients who are reluctant to have the full colonoscopy scan.
PillCam Colon was approved in the European Union in 2009 and it is also on the market in Latin America, parts of Asia. The device has not been approved in the U.S.