PENTAX Medical receives FDA clearance for 4K video processor, other devices

PENTAX Medical America Inc., a division of HOYA Group, has obtained US FDA 510(k) clearance for two of its latest innovations: the PENTAX Medical INSPIRA™, a premier 4K video processor, and the i20c video endoscope series. Developed with a focus on the needs of healthcare providers, the new video processor upgrades PENTAX Medical endoscope models[1] to the latest crystal-clear imaging and sets new standards in endoscopy. The 4K video processor and endoscope series will become commercially available in October 2023.

4k imaging option and the latest image processing power
The PENTAX Medical INSPIRA™ video processor is controlled via a customizable, state-of-the-art touch panel, equipped with innovative image enhancement functionalities and 4K image processing. Engineered with two connection types, it allows users to fully utilize the range of the PENTAX Medical endoscopy portfolio[1] to build a highly customized fleet. This intelligent feature extends the lifecycle of each endoscope for greater sustainability and economic savings while continuing to meet the highest standards of modern imaging, including the option of crystal-clear 4K visualization[2].

Image enhancement technology clinically proven to improve Adenoma Detection Rate (ADR)
The PENTAX Medical INSPIRA™ video processor also includes the acclaimed i-SCAN post-processing image enhancement technology. i-SCAN provides an enhanced view of the mucosal surface and blood vessels. In a recent study, using i-SCAN led to a 10 percent point increase in Adenoma Detection Rate (ADR) over the use of High Definition White Light alone[3]. i-SCAN features, along with Optical Enhancement (OE) technology and a new Auto High Dynamic Range (HDR) function, are all customizable and accessible via the INSPIRA touchscreen interface and programmable endoscope buttons.

Next-generation endoscopes with improved ergonomics and maneuverability
The unique control body of the i20c endoscopes is engineered to fit comfortably into each endoscopist’s grip with improvements to weight, positioning of buttons, and access to angulation wheels, among other control body changes. i20c endoscopes also utilize PENTAX Medical insertion tube technology with the addition of an adjustable stiffener. These dynamic insertion tube tools facilitate maneuverability as physicians move through challenging anatomies. To further improve clinical access, the standard i20c colonoscope (EC38-i20cL) also includes a 210° Retroview™ function.

David Harrison, President of PENTAX Medical Americas, comments: “The PENTAX Medical INSPIRA™ video processor and i20c Endoscopes are a milestone for endoscopy in the United States. This platform not only addresses current ergonomic needs but sets future standards in the endoscopy workflow that will ultimately strengthen the provider and patient experience. Together, the system empowers endoscopists with the economic flexibility, a 4K imaging option, and maneuverability tools they need to improve patient care.”
MB Bureau