Armstrong submits neurosurgical robot to the FDA
This article was originally published in Clinica
Executive Summary
Neurosurgical robot maker Armstrong Healthcare has submitted to the FDA a 510(k) application for clearance to sell its PathFinder system in the US. The image-guided device, which is already CE-marked for sale in Europe, can allow surgeons to perform intracranial surgery more accurately, while reducing the duration and complexity of procedures. As well as its uses in procedures ranging from routine brain tumour biopsies to complex functional neurosurgery, the system may also have application in ground-breaking techniques such as gene therapy, claims the UK firm.