Brain Navi Biotechnology has received certification from the Taiwan Food and Drug Administration for KrystoLens, its single-use neuro-endoscope, marking a regulatory milestone for the company’s medical imaging and endoscopic portfolio.
The certification addresses growing demand for minimally invasive surgical tools that can support procedural efficiency while reducing infection-related risks. In neurosurgery and endoscopic applications, device usability, field of view and sterility are important considerations for clinical adoption.
KrystoLens is designed as a single-use neuro-endoscope that aims to reduce the risk of cross-infection, improve ease of operation and expand the surgical field of view. The product’s disposable format may be relevant for hospitals seeking to reduce reprocessing burden and improve procedural readiness.
The TFDA certification confirms that KrystoLens complies with Taiwan’s medical device regulatory requirements and enables its formal introduction into the local healthcare market. Brain Navi plans to begin a full-scale market push in Taiwan in the second half of 2026.
Commercial adoption will depend on clinical familiarity, hospital procurement decisions, distribution partnerships and evidence of workflow value in surgical settings. The company has stated that it will work with medical institutions, distribution partners and clinical professionals to support uptake.
