Miniature medical device developer CapsoVision said today it won FDA 510(k) clearance for its novel CapsoCam Plus small bowel capsule endoscope system.
The Saratoga, Calif.-based company’s system is designed to provide a 360 degree panoramic lateral image of the small bowel for the detection of small bowel abnormalities. The full system consists of a capsule endoscope, retrieval kit, data access system and associated software.
The company’s CapsoCam Plus is a 3rd gen product for the company, but is the 1st to be commercialized in the U.S. CapsoVision won FDA 510(k) clearance for the 1stgen CapsoCam SV-1 small bowel capsule endoscope earlier this year.
“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. 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,” prez Johnny Wang said in a press release.