FDA News

FDA clears endoscopy platform for use at ambulatory surgery centers

The FDA has given 510(k) clearance to the IMAGINA Endoscopy System, an endoscopy platform for gastrointestinal procedures at ambulatory surgery centers, according to a press release from the manufacturer, PENTAX Medical.

“It’s a completely new concept in endoscopy, featuring new technology that delivers superior visualization with an attractive cost model,” Stepan Suchanek, MD, PhD, of the Centre for Gastrointestinal Endoscopy in Czech Republic, said in the release. “Overall, it helps us provide efficient and effective treatment while reducing financial burdens to the health system.”

Ambulatory surgery centers are growing in the United States and are in a position to offer efficient and cost-effective gastrointestinal procedures, according to the release.

The IMAGINA system includes a touch-screen LCD interface and displays images in a 1080p resolution. The system, according to the release, eliminates the need for periodic bulb replacements, which can add to concerns about cost for ambulatory surgery centers.

The system also includes another product from PENTAX that provides an enhanced view of the texture of the mucosal surface and blood vessels.

“We feel that today’s ASC market is underserved,” David Woods, PENTAX Medical, Americas President and CEO, said in the release. “These practices are often limited to used or previous-generation equipment to stay within budget. The launch of the IMAGINA allows us to best serve the needs of the core GI market and our system provides maximum cost predictability without compromising on the standard of care delivered to patients. IMAGINA eliminates the costliest components of a premium GI endoscopy system and still adheres to the highest imaging standards in the industry.”

The FDA has given 510(k) clearance to the IMAGINA Endoscopy System, an endoscopy platform for gastrointestinal procedures at ambulatory surgery centers, according to a press release from the manufacturer, PENTAX Medical.

“It’s a completely new concept in endoscopy, featuring new technology that delivers superior visualization with an attractive cost model,” Stepan Suchanek, MD, PhD, of the Centre for Gastrointestinal Endoscopy in Czech Republic, said in the release. “Overall, it helps us provide efficient and effective treatment while reducing financial burdens to the health system.”

Ambulatory surgery centers are growing in the United States and are in a position to offer efficient and cost-effective gastrointestinal procedures, according to the release.

The IMAGINA system includes a touch-screen LCD interface and displays images in a 1080p resolution. The system, according to the release, eliminates the need for periodic bulb replacements, which can add to concerns about cost for ambulatory surgery centers.

The system also includes another product from PENTAX that provides an enhanced view of the texture of the mucosal surface and blood vessels.

“We feel that today’s ASC market is underserved,” David Woods, PENTAX Medical, Americas President and CEO, said in the release. “These practices are often limited to used or previous-generation equipment to stay within budget. The launch of the IMAGINA allows us to best serve the needs of the core GI market and our system provides maximum cost predictability without compromising on the standard of care delivered to patients. IMAGINA eliminates the costliest components of a premium GI endoscopy system and still adheres to the highest imaging standards in the industry.”

    Perspective
    John Vargo

    John Vargo

    It’s an exciting development as it is evolving the endoscopic platform past fiberoptic transmission of an image to a totally electronic one.

    In my opinion, this will result in an improved fidelity of the image.

    Because of the resultant weight reduction, it may also result in an ergonomic benefit. 

     

    • John Vargo, MD, MPH
    • Director
      Enterprise Endoscopy Operations
      Cleveland Clinic

    Disclosures: Vargo reports he is a consultant for Meditech.