Boston-based digital surgery company Zeta Surgical announced on Wednesday that its 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.
The Zeta Surgical platform is designed to provide rapidly deployable, high-accuracy navigation for neurological interventions currently unsupported by existing navigation systems. Its guidance system uses mixed reality and advanced motion-aware remote sensing to enable real-time patient tracking, providing access to navigation across a wide range of neurological interventions.
This latest FDA approval enables the Zeta system to be deployed with a variety of new accessories and surgical kits, including instruments from IZI Medical. It will also allow hospitals to integrate the system's software into their IT networks, allowing for seamless and fast access to patient data.
Akeso's ligufalimab (CD47 mAb) granted FDA Orphan Drug Designation for AML
Krystal Biotech receives FDA approval for updated VYJUVEK label
Renalytix signs collaboration agreement with Tempus AI to expand KidneyIntelX.dkd access
Biophytis secures Brazilian funding and partnerships for obesity Phase 2 trial
Zhimeng Biopharma's investigational drug gains Phase 2 epilepsy clinical trial approval in China
Sanofi's SAR402663 granted FDA fast track designation for wet AMD
Implantica produces 10,000 RefluxStop units ahead of planned US launch