IMAGINA Endoscopy System Receives FDA Approval and Launches in the USA

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PENTAX Medical today announced that it has received US FDA 510(k) clearance for its IMAGINA Endoscopy System, an innovative endoscopy platform for gastrointestinal (GI) procedures at Ambulatory Surgery Centers (ASCs). IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

ASCs across the United States are currently experiencing exponential growth, most notably in gastroenterology. ASCs are positioned to perform fundamental GI procedures efficiently and cost-effectively, leading to increases in procedure volume. However, rising capital equipment costs and declining reimbursement rates present a significant challenge for clinics looking to provide quality care at a lower cost per procedure. With this in mind, PENTAX Medical developed an ideal solution that meets the needs of ASC’s and eliminates the trade-off between cost and quality care.

The IMAGINA System features a sleek, touch-screen LCD interface on the processor and displays brilliant images in crisp 1080p resolution, all while providing greater cost predictability by eliminating the need for expensive periodic bulb replacements. IMAGINA includes PENTAX i-SCAN, a real-time, digital image enhancement technology that provides the user with an enhanced view of the texture of the mucosal surface and the blood vessels.

“What I really like about the IMAGINA is that it’s not just a small improvement to what we already have,” said Dr. Stepan Suchanek, Centre for Gastrointestinal Endoscopy, Prague, Czech Republic. “It’s a completely new concept in endoscopy, featuring new technology that delivers superior visualization with an attractive cost model. Overall, it helps us provide efficient and effective treatment while reducing financial burdens to the health system.”

Additionally, the IMAGINA i10c series is the only endoscope platform to provide distally mounted LED lights, an HD+ CMOS image sensor, and PENTAX i-SCAN—features that provide pristine, crystal-clear visualization for confident assessment of the GI tract. The i10c series also offers greater ergonomic comfort for the endoscopist, with scopes that are up to 20–25% lighter and a waterproof connector that is 40% lighter1, delivering greater convenience to reprocessing staff.

“We feel that today’s ASC market is underserved,” said David Woods, President, and CEO of PENTAX Medical, Americas. “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: a true testament to our commitment to better patient outcomes, improved patient experience and a lower overall cost of care.”

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