KrystoLens from Brain Navi Receives TFDA Certification, Set to Enter Taiwan Market

Brain Navi Biotechnology Achieves Key Regulatory Milestone Following Recognition at the 22nd National Innovation Award

ZHUBEI, June 3, 2026 /PRNewswire/ — Brain Navi Biotechnology announced that its KrystoLens, the single-use neuro-endoscope, has officially received certification from the Taiwan Food and Drug Administration (TFDA), marking an important milestone in the company’s development in medical imaging and endoscopic applications.

Following its recognition at the 22nd National Innovation Award earlier this year, KrystoLens has once again gained attention for its product innovation and clinical potential. The TFDA certification confirms that the product complies with Taiwan’s medical device regulatory requirements and paves the way for its formal introduction into the local healthcare market.

Developed with clinical needs in mind, KrystoLens is designed to help reduce the risk of cross-infection, improve ease of operation, and expand the surgical field of view. Brain Navi Biotechnology aims to provide medical institutions with a more efficient and flexible endoscopic solution.

With demand for minimally invasive surgery and high-quality medical imaging continuing to grow, Brain Navi plans to begin a full-scale market push in Taiwan in the second-half of 2026 and will be working closely with medical institutions, distribution partners, and clinical professionals to accelerate the adoption of KrystoLens in clinical settings.

Brain Navi Biotechnology stated that the TFDA certification represents a key step in the commercialization of KrystoLens and reflects the company’s continued progress in research and development, quality management, and regulatory strategy.

Looking ahead, Brain Navi Biotechnology will make Taiwan an important starting point for building clinical experience, expanding market presence, and supporting future international development. Through KrystoLens, Brain Navi Biotechnology aims to bring new possibilities to medical imaging technology and contribute to the growth of Taiwan’s medical technology industry.

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