March 4, 2016 – SARATOGA, Calif. – March 4, 2016 – CapsoVision is pleased to announce it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for CapsoCam® SV-1.
CapsoCam is the only small bowel capsule endoscope technology that captures a full 360º panoramic lateral image of the small bowel mucosa and is the only capsule endoscope that uses wire-free technology, eliminating the need for expensive and uncomfortable receiver equipment.
Because of CapsoCam’s unique design, patients experience unparalleled patient freedom and comfort during the procedure while clinicians have more flexibility in scheduling procedure room time.
The clinical study submitted to the FDA was designed to demonstrate that CapsoCam SV-1 is safe and effective for the intended use of visualization of the small bowel mucosa in adults, and it may be used as a tool in the detection of abnormalities of the small bowel
The study compared CapsoCam SV-1 to PillCam® SB2.
Results from the multi-center study demonstrate that CapsoCam SV-1 performs in a manner that is substantially equivalent to PillCam SB2 and has a comparable safety profile as PillCam SB2.
In a patient questionnaire administered during the study, ~80% patients indicated that they preferred the CapsoCam system to the PillCam system.