The US Food and Drug Administration (FDA) has granted 510k clearance to Germany-based medical technology company fiagon‘s brain navigation software.
The FDA clearance encompasses the company’s navigation system and software, BiopsyPointer FlexPointer 1.5 and ShuntPointer.
Fiagon’s Navigation system uses an electromagnetic tracking system to detect surgical instruments during surgery related to the patient’s CT scan.
Fiagon’s technology features instruments which leverage on the company’s patented ‘chip on the tip’ technology, including bendable instrumentation to provide access to the challenging anatomy.
The use of surgical navigation tools enables surgeons to reduce the risk to patients and decrease surgery time by reducing the number of instrument changes.
Fiagon president Wolfgang Urbild said: "With the new regulatory clearance we will bring a wider range of surgical navigation tools to surgeons in the US 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."
Fiagon’s navigation set for brain interventions is designed to allow surgeons flexibility and easier navigation of craniotomies, scull base procedures, cranial biopsies and general catheter placement.
The technology includes the Navigation module with Navigation software; navigation sensor; navigation instrument; patient reference localiser; ShuntPointer; FlexPointer 1.5; BiopsyPointer.
The Brain navigation system and instrument set have previously received regulatory clearance in EMEA, Australia and Russia. It is currently marketed in more than 50 countries.