New NI Medical (2011) Ltd.

New NI Medical (2011) Ltd. specializes in devices for intraoperative monitoring. Specifically, they produce the NICaS CS, which is designed for continuous spinal cord monitoring during surgical procedures. This device helps surgeons assess neural function in real-time, ensuring safer surgical outcomes.

The company is headquartered in Israel. This location allows them to focus on developing and manufacturing medical devices tailored to global surgical monitoring needs, particularly in regions where intraoperative neural monitoring is critical.

The NICaS CS, one of New NI Medical’s devices, is listed in the eudamed registry, which is the European Union’s centralised database for medical devices. Listing in eudamed ensures transparency and compliance with EU regulatory requirements for Class IIa devices.

The NICaS CS falls under Class IIa classification, which is determined by its intended use—continuous spinal cord monitoring during surgery. Class IIa devices are considered moderate-risk, requiring compliance with specific EU directives (e.g., MDR/AIMD) to ensure safety and performance before market placement.