CapsoVision gets FDA 510(k) clearance for CapsoCam Plus

14 November 2016 (Last Updated November 14th, 2016 18:30)

US-based medical device innovator CapsoVision has obtained the US Food and Drug Administration (FDA) 510(k) clearance for the CapsoCam Plus small bowel capsule endoscope system.

US-based medical device innovator CapsoVision has obtained the US Food and Drug Administration (FDA) 510(k) clearance for the CapsoCam Plus small bowel capsule endoscope system.

CapsoCam Plus consists of a capsule endoscope, a retrieval kit, a data access system, and software, which work together to facilitate a streamlined, patient-friendly examination and does not require the patient to wear receiver equipment during the examination.

The system Plus has been designed to provide a 360º panoramic lateral image of the small bowel to detect small bowel abnormalities.

"Without the need for capital equipment, the barriers to entry are significantly reduced, and physicians can perform more capsule endoscopy procedures more flexibly."

The images are stored in a flash memory system within the capsule.

The in vivo images and other data are collected during a CapsoCam Plus examination, by placing the capsule into the CapsoAccess system and click download which is then accessed using CapsoView software, available for both Microsoft Windows and Mac OSX operating systems.

CapsoVision President Johnny Wang said: “Without the need for capital equipment, the barriers to entry are significantly reduced, and physicians can perform more capsule endoscopy procedures more flexibly while minimising expenses related to staffing and exam room time.

“In fact, last month in Europe, one of our physician panel presenters also reported reduced reading time with our new software, so the potential time-savings of a CapsoCam Plus examination are significant and extend to each aspect of the exam process.”