Zeta Surgical has announced that its artificial intelligence (AI)-powered Zeta navigation system has received 510(k) clearance from the US Food and Drug Administration (FDA) for use with expanded instruments and enhanced hospital connectivity.
According to a company press release, the Zeta platform provides rapidly deployable, high-accuracy navigation for “the 19.6 million annual neurological interventions currently unsupported by existing navigation systems”. Its ‘GPS-like’ guidance system uses mixed reality and advanced motion-aware remote sensing to enable real-time patient tracking, providing “unprecedented access” to navigation across a wide range of neurological interventions, the release adds.
This latest FDA clearance enables the Zeta system to be deployed with a variety of new accessories and surgical kits, including instruments from technology leaders like Izi Medical. The clearance will also allow hospitals to integrate the system’s software into their IT networks, allowing for seamless and fast access to patient data, according to Zeta.
“Our vision is to ensure that advanced image-guided technology is no longer confined to specialised operating rooms or surgical suites,” said Hieu Le Mau, Zeta’s chief operating officer. “The addition of new surgical kits substantially broadens the system’s applications, opening up new possibilities in neurosurgical procedures, while the enhanced connectivity with hospital systems allows surgeons to easily transfer and access patient information.”
The recent 510(k)-related announcement comes as the company starts to roll out its Pioneers programme—its first set of commercial pilots aimed at evaluating the use of the Zeta system across a variety of clinical applications.
“We are excited about the impact our expanded capabilities will have on our pilot programmes across the USA,” said Raahil Sha, co-founder and chief technology officer of Zeta. “Our goal has always been to improve surgical outcomes, and this clearance opens up a significantly broader range of procedures that our partner hospitals can access through our minimally invasive system.”
In 2023, Zeta obtained its first US FDA 510(k) clearance for the Zeta navigation system and, earlier this year, announced the successful completion of its first multicentre clinical trial at two leading sites in Singapore as well. The trial involved 15 patients requiring elective and emergency ventriculostomy that saw all patients successfully cannulated in a single attempt, and with no adverse events.
“We feel very privileged and excited to be part of the forefront of MedTech,” said Min Wei Chen (National Neuroscience Institute [NNI]/Singapore General Hospital, Singapore), who led the trial. “It has been an enlightening journey watching how the project evolved from the lab to the operating theatre. The results of the trial speak for themselves. We have learned such valuable lessons together as a team and look forward to the future where I am sure this navigation platform will become one of the key ‘must-haves’ in the modern neurosurgical unit.”
