PENTAX Medical Achieves FDA 510(k) Clearance for INSPIRA™ Visual Processor and i20c Endoscopes with Enhanced Ergonomics in the U.S

Wednesday, August 09, 2023

PENTAX Medical America, a division of the esteemed HOYA Group, has successfully received FDA 510(k) clearance for two groundbreaking innovations: the cutting-edge PENTAX Medical INSPIRA™, a state-of-the-art 4K video processor, and the forward-thinking i20c video endoscope series. These advancements have been meticulously designed with a strong emphasis on meeting the unique needs of healthcare providers, pushing the boundaries of crystal-clear imaging and revolutionizing the field of endoscopy.

These remarkable developments are expected to make their debut in the market come October 2023, bringing with them a wave of anticipation. The PENTAX Medical INSPIRA™ video processor features an intuitive, fully customizable touch panel interface that incorporates pioneering image enhancement capabilities and unparalleled 4K image processing. Boasting compatibility with two distinct connection types, this innovative processor empowers users to unlock the full potential of the extensive PENTAX Medical endoscopy portfolio, facilitating the creation of a versatile and tailored fleet of instruments. This approach not only enhances sustainability and cost-effectiveness by prolonging the lifespan of each endoscope but also maintains the highest standards of contemporary imaging, including the option for pristine 4K visualization.

A remarkable attribute of the PENTAX Medical INSPIRA™ video processor is its integration of the highly esteemed i-SCAN post-processing image enhancement technology. This cutting-edge addition enhances the visualization of mucosal surfaces and blood vessels, resulting in a remarkable 10 percent point increase in Adenoma Detection Rate (ADR) when compared to the use of High Definition White Light alone, as corroborated by recent research. Complementing i-SCAN are Optical Enhancement (OE) technology and an innovative Auto High Dynamic Range (HDR) function, all of which are easily customizable and accessible via the user-friendly INSPIRA touchscreen interface and programmable endoscope buttons.

Representing a significant milestone in the field of endoscopy within the United States, the PENTAX Medical INSPIRA™ video processor and i20c Endoscopes go beyond addressing current ergonomic requirements. They pave the way for future benchmarks in the endoscopy workflow, ultimately enhancing both provider and patient experiences. Together, this integrated system equips endoscopists with unmatched economic flexibility, a cutting-edge 4K imaging option, and a comprehensive suite of maneuverability tools, synergistically contributing to an elevated standard of patient care.



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