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# FDA Clears Fiagon 510(k) for Brain Navigation Software
- URL: https://www.fdaweb.com/fda-clears-fiagon-510-k-for-brain-navigation-software/
- Published: 2016-04-22T12:00:00.000Z
- Updated: 2026-09-14T20:56:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135476

> FDA has cleared a Fiagon 510(k) for its brain navigation software, BiopsyPointer FlexPointer 1.5 and the ShuntPointer. The device uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient’s CT scan. It relies on instruments that have a proprietary “chip on the tip” technology, including bendable instrumentation to reach challenging anatomy. “The use of surgical navigation tools allows surgeons to significantly reduce the risk to patients of each intervention and shorten surgery time by reducing the number of instrument changes,” the company says.