Neuron-Spectrum-AM is FDA approved!

Neuron-Spectrum-AM is FDA approved!

  • 5 December 2022
  • EEGAchievements

The last day of autumn 2022 is a special day for Neurosoft as having done a great and difficult team work — we successfully registered Neuron-Spectrum-AM system in the USA. The document can be found in the Official Documents section or here.

FDA requirements are considered one of the most demanding in the industry of medical devices, so obtaining the FDA certificate is another confirmation of the high quality of Neuron-Spectrum-AM system.

Neuron-Spectrum-AM is a wearable 21-channel ambulatory EEG recorder with wireless interface, built-in memory, control buttons and display. The system allows conducting long-term (up to 2 days) video EEG monitoring as well as saving data to the built-in memory card. Both electrode caps and standard EEG electrodes can be used for recording. The system can be used in the EEG laboratory, the clinic ward not particulalry equipped for EEG studies and even at the patient's place. Thanks to the wireless interface, the patient has complete freedom of movement.