SYNEIKA

SYNEIKA manufactures the SYNEIKA ONE, a device designed for transcranial magnetic stimulation (TMS) with neuronavigation. This technology is used for therapeutic neuromodulation, specifically in managing chronic pain, treating treatment-resistant major depression, and aiding stroke rehabilitation. The device delivers targeted brain stimulation based on real-time brain mapping to improve patient outcomes in these conditions.

SYNEIKA is based in France, where it operates under the applicable EU regulatory requirements. Since its device, the SYNEIKA ONE, is classified as a Class IIb medical device, it must comply with EU directives such as the Medical Device Regulation (MDR) or the Active Implantable Medical Device Directive (AIMDD), depending on the specific application. This classification ensures higher scrutiny for devices that pose moderate risks to patients.

SYNEIKA’s devices are listed in the EU’s eudamed database, which is the official EU registry for medical devices. Registration in eudamed is mandatory for manufacturers to demonstrate compliance with EU regulatory requirements and to facilitate transparency in the medical device supply chain. This listing helps healthcare professionals, regulators, and other stakeholders verify the device’s legal status within the EU.

The SYNEIKA ONE is classified as a Class IIb medical device under EU regulations. This classification is determined based on factors like the device’s intended purpose, potential risks to patients, and the duration of use. Class IIb devices are considered to pose moderate risks and require additional scrutiny, including clinical evaluations and conformity assessments, to ensure their safety and performance before they can be placed on the market.