Armstrong submits neurosurgical robot to the FDA
This article was originally published in Clinica
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.
"The submission of PathFinder's 510(k) is an important milestone for the company," says Patrick Finlay, the High Wycombe firm's managing director. "The performance of the product is meeting our best expectations, and European market reaction is extremely encouraging."
Following hospital trials conducted in the UK, Armstrong Healthcare says it is establishing a number of PathFinder beta-sites at leading centres in the UK and mainland Europe during 2004. The full international launch of the product is scheduled for the fourth quarter of 2004.