Bionen Medical Devices

Bionen is an Italian medical device manufacturer focused on neurophysiology and neurodiagnostics. The company designs and produces electrodes, accessories, and related consumables used to record biological signals for applications including electroencephalography, electromyography, evoked potentials, polysomnography, nerve conduction studies, and intraoperative neuro monitoring. Its portfolio includes needle electrodes, surface electrodes, prewired headcaps, stimulating probes, gels, and related signal acquisition accessories. Bionen manufactures in Italy, operates under ISO 13485 quality standards, and reports compliance with EU MDR requirements, with FDA clearance for certain products. The business is commercial-stage and serves distributors and clinical customers across more than 30 countries.