UPDATED: Given wins FDA nod for next-gen PillCam device

Given's PillCam SB won FDA 510(k) clearance.--Courtesy of Given

Given Imaging ($GIVN) won the FDA's 510(k) clearance for a next-generation version of its PillCam SB, and the Israeli device company is eyeing a rapid rollout. The updated product will launch in the U.S. during the 2013 fourth quarter, something that should help reverse a regional sales dip.

Investors reacted favorably to the news. Given's stock hit $17.13 in early trading on Aug. 13, up nearly 5%. PillCam SB 3 is cleared to detect and monitor problems in the small bowel related to Crohn's disease, obscure gastrointestinal bleeding and iron-deficiency anemia.

Given has long relied on the PillCam SB as a signature part of its business, and the company says the medical community has turned to the system for 2 million procedures since its first-generation launch. But PillCam SB sales in the Americas region dipped 2% in the 2013 second quarter and declined 5% for the first half of 2013, despite a robust revenue picture for the product, and company, overall. A product refresh can reverse this, particularly in the U.S., which is the world's largest healthcare market.

"We believe there will be a very positive impact from the capsules on U.S. sales," company president and CEO Homi Shamir told FierceMedicalDevices.

Shamir explained that Given already has market approval for the updated product in Germany, Australia and Canada, and that the company is getting "very positive feedback" from physicians in those markets. But it will take time for that to take hold in the U.S. and the Americas. Shamir said the impact will be more strongly felt in 2014 and beyond, after customers upgrade related software, including the data recorder that patients wear around their waist while the capsule passes through the digestive system.

Given says its PillCam SB 3 builds on earlier models, with a 30% improvement in image resolution and a more advanced video-processing engine. The product is also designed to give more detailed images and broader coverage of the small bowel, and its software updates are intended to boost the efficiency of the video compilation process as the capsule passes through a patient's digestive system.

Japanese regulators signed off on Given's PillCam Colon device in July, giving the product entry into the world's second-largest healthcare market. Given recently reported an aggressively successful 2013 second quarter, posting $49.5 million in sales and $5.2 million in net income. This was a best-ever second quarter for Given, which abandoned plans to sell itself in January.

- read the release

Editor's note: This story has been updated to include comments from Given Imaging CEO Homi Shamir.

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