Montvale, N.J.-based Pentax Medical has received FDA 510(k) clearance for the Imagina Endoscopy System, an endoscopy platform for gastrointestinal (GI) procedures. Specifically, Imagina offers practitioners a platform to visualize anatomy, improve the operator experience, and streamline long-term patient care costs.

Addressing an Issue

Ambulatory surgical centers (ASCs) across the United States are currently experiencing exponential growth, most notably in gastroenterology, Pentax Medical officials say. Moreover, 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. Pentax Medical developed the Imagina Endoscopy System with these needs in mind,

Key Product Features

The Imagina system features a touch-screen LCD interface on the processor and displays images in 1080p resolution, while eliminating the need for periodic bulb replacements. Moreover, 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,” says Stepan Suchanek, MD, PhD, 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 endoscope platform provides distally mounted LED lights, an HD+ CMOS image sensor, and Pentax i-SCAN™—features that provide advanced 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% to 25% lighter and a waterproof connector that is 40% lighter, delivering convenience to reprocessing staff.

“We feel that today’s ASC market is underserved,” says 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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