PENTAX Medical receives FDA 510(k) clearance for 4K video processor, PENTAX Medical INSPIRA™ (EPK-i8020c) and the ergonomic i20c endoscopes in the United States

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Aug 08, 2023, 10:00 ET

MONTVALE, N.J., Aug. 8, 2023 /PRNewswire/ -- 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."

Physicians interested in early access to updates on the availability of the INSPIRA and i20c endoscopes can sign up at seethefuture.pentaxmedical.com.

About PENTAX Medical

PENTAX Medical is a division of HOYA Group. The company's mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY.

PENTAX Medical strives to align with the healthcare community's Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider's experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support.

Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations.

For more information: http://www.pentaxmedical.com/us

About HOYA

Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA is active in the fields of healthcare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, and optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people. For more information, please visit: http://www.hoya.com.

1 90i, i10, J10, 90K, i10c and i20c series endoscopes.
Not all models are compatible. For detail, contact your local PENTAX Medical service facility.
2 4K visualization depends on the resolution of the endoscope model.
3 Kidambi, T. D. (2019). Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy. Clin Gastroenterol Hepatol., 17(4), 701-708.e1 https://doi.org/10.1016/j.cgh.2018.06.024.

SOURCE PENTAX Medical