Fiagon AG medical technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its brain navigation software.


The approval includes the company’s navigation system and software, BiopsyPointer FlexPointer 1,5 and the ShuntPointer.

By using an electromagnetic tracking system, the navigation system will locate surgical instruments during a surgery in relation to a patient´s CT scan.

Fiagon’s technology features instruments that have a chip on the tip technology and bendable instrumentation to reach challenging anatomy.

The navigation set for brain interventions is developed to offer surgeons with flexibility and easier navigation of craniotomies, skull base procedures, cranial biopsies and general catheter placement.

The set comprise of navigation module with navigation software, navigation sensor, navigation instrument, patient reference localizer, shuntpointer, flexpointer and biopsypointer.

Earlier, the brain navigation system and instrument set secured approval in EMEA, Australia and Russia. They are currently marketed in around 50 countries.

Fiagon NA president Wolfgang Urbild said: "With the new regulatory clearance we will bring a wider range of surgical navigation tools to surgeons in the U.S. and continue our expansion in the North American market.

"Fiagon´s smart system with a small footprint, enables surgeons to increase patient safety during standard and critical brain surgeries."

Image: Fiagon has obtained FDA approval for its brain navigation software. Photo: courtesy of Stuart Miles /