Brain Navi Biotechnology has received US Food and Drug Administration (FDA) 510(k) clearance for NaoTrac, the company’s stereotaxic guiding surgical device. In a press release, Brain Navi notes that—following previous approval from the Taiwan Food and Drug Administration (TFDA) and CE-mark certification in Europe—this milestone reinforces its “commitment to innovation, patient safety and continuous improvement” in the neurosurgical field.
The release goes on to describe the 510(k) clearance as a “significant step forward” that opens the door to new, high-potential markets while affirming the quality and reliability of Brain Navi’s flagship robotic system.
“This milestone not only expands our global footprint, but also validates the years of clinical research and development invested in the technology,” the release adds.
Having received 510(k) clearance from the US FDA, the company now plans to bring NaoTrac to hospitals and surgical teams in the USA in order to help them achieve “even higher levels of precision and efficiency in the operating room”.
Key Features of NaoTrac outlined by Brain Navi include autonomous navigation and robotic, artificial intelligence (AI)-driven precision, as well as a number of neurosurgical applications, such as biopsies, tumour ablations, endoscopic interventions, external ventricular drain (EVD) placement, stereoelectroencephalography (SEEG), and deep brain stimulation (DBS).
“This step marks a before-and-after moment for Brain Navi—one that paves the way for broader international adoption,” the company’s release notes. “As we move forward, we expect to see more and more NaoTrac systems installed around the world, supporting surgical teams and improving patient care across borders.”
