FHC, Inc. Announces EU MDR Certification of ATLAS™ Neurophysiology System

Bowdoinham, ME — June 10, 2026 — FHC, Inc., a leading manufacturer of precision medical devices for neurosurgery and neuroscience research, today announced that its ATLAS™ Neurophysiology System has received CE certification under the European Union Medical Device Regulation (EU) 2017/745. This milestone enables expanded availability of the system in European markets in accordance with MDR requirements.

The ATLAS Neurophysiology System is designed for the clinical environment and manages clinical and research electrophysiological signals from both macro- and microelectrodes through a network infrastructure supporting distributed processing and analysis. A single amplifier records multi-scale signals of widely differing impedances delivered through microwire pre-amplifiers and buffered headboxes.

The system supports advanced recording applications in epilepsy, deep brain stimulation (DBS), and cognitive electrophysiology, and is intended for the temporary recording and monitoring of brain electrical activity.