FDA News

FDA clears small bowel capsule endoscope

The FDA has granted 510(k) clearance for the CapsoCam Plus small bowel capsule endoscope, the manufacturer announced.

CapsoCam Plus (CapsoVision) is the third-generation small bowel capsule endoscope manufactured by the company, but the first to be commercialized in the U.S., according to a press release.

Earlier this year, the FDA granted 510(k) clearance to the first-generation SV-1 version of the device — which was commercially available internationally since 2011 — based on data showing comparable safety and performance to the end-facing PillCam SB2. Survey results from the same study also showed 80% of patients preferred the CapsoCam over the PillCam device, according to the press release.

The CapsoCam Plus is marketed as the only capsule endoscopy system that provides a comprehensive 360-degree panoramic lateral image of the small bowel and without requiring patients to wear receiver equipment during the procedure. The system includes a capsule endoscope, a retrieval kit, a data access system and software.

Like its predecessor, the new iteration of the device also includes a flash memory system to store images collected during the procedure, but its redesigned imaging hardware provides almost twice the resolution.

“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,” Johnny Wang, president of CapsoVision, said in the press release. “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.”

Disclosures: Wang is employed by CapsoVision.

The FDA has granted 510(k) clearance for the CapsoCam Plus small bowel capsule endoscope, the manufacturer announced.

CapsoCam Plus (CapsoVision) is the third-generation small bowel capsule endoscope manufactured by the company, but the first to be commercialized in the U.S., according to a press release.

Earlier this year, the FDA granted 510(k) clearance to the first-generation SV-1 version of the device — which was commercially available internationally since 2011 — based on data showing comparable safety and performance to the end-facing PillCam SB2. Survey results from the same study also showed 80% of patients preferred the CapsoCam over the PillCam device, according to the press release.

The CapsoCam Plus is marketed as the only capsule endoscopy system that provides a comprehensive 360-degree panoramic lateral image of the small bowel and without requiring patients to wear receiver equipment during the procedure. The system includes a capsule endoscope, a retrieval kit, a data access system and software.

Like its predecessor, the new iteration of the device also includes a flash memory system to store images collected during the procedure, but its redesigned imaging hardware provides almost twice the resolution.

“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,” Johnny Wang, president of CapsoVision, said in the press release. “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.”

Disclosures: Wang is employed by CapsoVision.