Neurosoft , Ltd.

Neurosoft, Ltd. specializes in intraoperative neuromonitoring (IONM) systems. These include hardware like the Neuron-Spectrum-AM, Neuron-Spectrum-4/P, and Neuro-IOM systems, each paired with proprietary software solutions (e.g., Neuron-Spectrum.NET or Neuro-IOM.NET). These devices are designed to monitor nerve function during surgery to reduce risks associated with spinal or peripheral nerve injuries.

Neurosoft, Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these devices as Class II, indicating a moderate level of risk that requires special controls to ensure safety and effectiveness. This classification influences how the devices are reviewed and cleared for market authorization.

Yes, Neurosoft, Ltd.’s devices are listed under FDA’s 510(k) clearance records. This registry confirms that each device has undergone a premarket submission process to demonstrate substantial equivalence to a legally marketed predicate device. Listing in this registry provides transparency for healthcare providers, regulators, and other stakeholders about the device’s regulatory status and compliance with FDA requirements.

Neurosoft, Ltd.’s devices are classified as Class II by the FDA. This classification means they pose a moderate risk to patients and require special controls beyond general controls (like good manufacturing practices) to ensure their safety and performance. While Class II devices don’t require premarket approval (PMA), they must comply with FDA’s 510(k) process to prove they’re substantially equivalent to existing cleared devices, ensuring they meet regulatory standards before entering the market.