In The Pipeline

Kubota Vision Receives ISO Certification

October 19, 2021

The Kubota Glass System has a self-contained battery that powers the micro-LED array to generate the peripheral defocus stimulus. The distance center segment contains the patient’s distance refractive error correction.

SEATTLE — Kubota Visiona subsidiary of Kubota Pharmaceutical Holdings Co., announced that it has received ISO 13485:2016 certification for the design and development of ophthalmic products and medical devices. 

ISO 13485 is an internationally recognized safety and quality standard for medical devices. Kubota Pharmaceutical group continues to pursue developing ophthalmic medical devices to satisfy unmet medical needs worldwide.

“ISO 13485 certificate demonstrates our high standard quality system in the development of medical devices, and we are proud to be awarded this certificate. We are in the final stage of launching Kubota Glass, a wearable device for myopia management, and continue maximizing the company’s value and strategically enhancing our business,” said Ryo Kubota, MD, PhD, Chairman, President and CEO of Kubota Vision Inc.

The company has the Kubota Glass System in development, which is designed to reduce myopia progression. The spectacles utilize a novel, augmented reality-based optical system. Longitudinal studies are now being performed on a Kubota Glass prototype on a pediatric cohort to determine the long-term effectiveness and, ultimately, the sustainability of this myopia control technology.

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