Silicon Valley medical device innovator CapsoVision, Inc. is pleased to announce that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CapsoCam® Plus small bowel capsule endoscope system.
CapsoCam Plus is an award-winning technology that provides a novel 360º panoramic lateral image of the small bowel, used for the detection of small bowel abnormalities. The system consists of a capsule endoscope, a retrieval kit, a data access system, and software, which work together to provide a streamlined, patient-friendly examination. CapsoCam Plus is the only capsule endoscope system that does not require patients to wear receiver equipment during the examination and is the only capsule endoscopy system that provides comprehensive 360º imaging. CapsoCam Plus is the third- generation CapsoCam capsule, but is the first to be commercialized in the U.S.
In early 2016, CapsoVision received FDA 510(k) clearance for its first generation CapsoCam SV-1 small bowel capsule endoscope, which had been commercially available internationally since 2011. The multi-center clinical study submitted to the FDA demonstrated that CapsoCam SV-1 has a similar safety profile and performs in a substantially equivalent manner to the end-facing capsule endoscopy system, PillCam® SB2. In a patient questionnaire administered during that study, nearly 80% of patients indicated that they preferred the CapsoCam system to the PillCam® system.
Like the earlier generation CapsoCam SV-1, CapsoCam Plus also utilizes a flash memory system within the capsule to store the 360º mucosal images collected during the examination, however the imaging hardware in CapsoCam Plus was redesigned to provide nearly double the resolution of CapsoCam SV-1.
To extract the in vivo images and other data collected during a CapsoCam Plus examination, users simply place the capsule into the CapsoAccess system and click download. The retrieved data is then easily accessed using CapsoView® software, available for both Microsoft Windows and Mac OSX operating systems.
"We are excited that the FDA has cleared CapsoCam Plus to launch in the U.S. We're really focused on bettering the capsule endoscopy examination process for patients and caregivers," said CapsoVision President, Johnny Wang.
"Without the need for capital equipment, the barriers to entry are significantly reduced, and physicians can perform more capsule endoscopy procedures more flexibly while minimizing 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. We're hopeful that our unique technology is able to make a positive impact in the U.S. as well, for both patients and clinicians."
CapsoVision, Inc. was recognized by Frost & Sullivan as the recipient of the 2016 European Enabling Technology Leadership award for their work in ongoing technology advancement and market growth in the capsule endoscopy market. CapsoVision was also honored for excellence in product differentiation in 2013.
