⚠️ The NeXus systems are passive physiological signal acquisition systems. Each NeXus does not deliver electrical stimulation, pulses, currents, or electromagnetic emissions intended to interact with the patient. Based on its technical design and mode of operation, it is not expected to pose a safety risk to individuals with pacemakers, implantable cardioverter defibrillators (ICDs), neurostimulators, or other active implantable medical devices.
However:
Mind Media has not conducted dedicated verification, validation, or clinical studies to formally establish compatibility or safety of the NeXus systems when used on patients with these implants. Therefore, no regulatory claims of proven safety or compatibility can be made.
Accordingly:
Regulatory Position
No known mechanisms exist that would cause interference with active implants.
No adverse interactions are expected given the passive, non-stimulating nature of the device.
Nonetheless, absence of evidence is not evidence of certification, and compatibility has not been formally evaluated per MDR Annex XIV or FDA guidance.
Professional Responsibility
Use of the a NeXus in individuals with pacemakers or other implants:
Is not prohibited,
Is not expected to be unsafe,
But must be applied under the clinical judgment and responsibility of the trained professional, taking into account:
The patient’s specific implant type,
The implant manufacturer’s cautions regarding external electronic equipment,
The intended procedure and operating environment.
Liability Statement
Mind Media does not accept liability for use in patient groups for which formal compatibility has not been established. Professional users must assess individual risks according to standard clinical practice.