Israel-based Given Imaging is on a roll, landing Japanese regulatory approval for its 3rd-generation PillCam technology, a swallow-able camera designed to help diagnose gastrointestinal disease.
The company has said in the past that the Japanese healthcare scene represents a potential 10-fold increase in the company’s total footprint, from around 1,000 patients reported in July to a market of over 1 million potential patients.
"Approval of the PillCam SB 3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract," Given Imaging president & CEO Homi Shamir said in prepared remarks. "Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB 3’s benefits into clinical practice."
The medical device maker just last month won FDA clearance for the PillCam SB 3 system, and in July announced initial Japanese clearance for PillCam Colon. Given Imaging initially submitted its FDA application in December 2012. The PillCam is cleared for use in Japan, Europe, Latin America, Canada and parts of Asia.
The PillCam device is designed for patients unwilling or unable to undergo traditional colonoscopy. Only 25% of the Japanese patient population goes in for their recommended fecal occult blood test, but the disease incidence rate is increasing, according to the company. The new PillCam SB 3 features updates to its capsule, recorder, sensor belt, and software that the company says improve image quality, tissue coverage and efficiency, according to a company statement.