Korea’s IntroMedic wins FDA nod for MiroCam capsule endoscope, inks U.S. distro deal

Korea-based medtech company IntroMedic inked a deal with Stratis Medical to distribute its MicroCam video capsule endoscopy system in the U.S.

The device is designed to visualize and monitor the small bowel mucosa. The MicroCam is the first capsule endoscopy system with E-Field Propagation or Human Body Communication, according to Stratis Medical – the proprietary tech uses the human body as a communication medium to provide high-resolution images for consistent and accurate monitoring of the small bowel.

The latest MicroCam system includes software that receives, records and processes images faster and more efficiently than previous iterations. The software also features positioning markers, automatic bleeding detection, a reference library and more, Stratis touted.

“We are honored and excited to be awarded the exclusive distributorship for IntroMedic’s MiroCam capsule endoscopy products in the United States,” Stratis CEO & president, William Bookwalter, said in prepared remarks.

“There are over four million cases of IBD and IDA in the U.S. alone, and a significant portion of these patients could benefit from an examination of the entire small bowel. MiroCam represents a best-in-class, leading alternative to current VCE technology and adds clinical value to the improvement in increasing diagnostic yield. We look forward to bringing this innovative technology along with exceptional customer service and technical support to the gastroenterology community and their patients,” he added.

Stratis also announced today that the dual-camera endoscopy device won 510(k) clearance from the FDA.

“The MiroCam VCE system combines hardware and software excellence and is a vital part of the care of the GI patient,” said Dr. Paul Akerman, chief medical officer & director of therapeutic endoscopy at University Gastroenterology in Providence, Rhode Island. “MiroCam is highly cost competitive and can have a significant and positive impact on the office-based GI practice.”

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