Hoya (TYO:7741) subsidiary Pentax Medical announced that it won FDA 510(k) clearance for its Imagina endoscopy system and initiated the device’s U.S. launch.
The Imagina system is designed to perform gastrointestinal (GI) procedures at ambulatory surgery centers (ASCs). It features a touch-screen LCD interface while eliminating the need for periodic bulb replacements. It also includes the Pentax i-Scan, a real-time, digital image enhancement system designed to offer an enhanced view of the texture of the mucosal surface and blood vessels.
Pentax touts the Imagina i10c series as the only endoscope platform with distally mounted LED lights, an HD+ CMOS image sensor and the Pentax i-Scan feature.
“We feel that today’s ASC market is underserved,” Pentax Medical, Americas, president & CEO David Woods said in a news release. “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.”
“What I really like about the Imagina is that it’s not just a small improvement to what we already have,” added Dr. Stepan Suchanek of the 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.”
