NMPA: 6 Innovative Products Approved for Listing!
On January 13, NMPA issued a notice that six innovative products such as “Neurosurgery Navigation and Positioning System” were approved for listing. Details:
Neurosurgery Navigation and Positioning System
The product is composed of infrared camera, workstation, support, positioning components (probe, reference frame, connector, reflective ball, surgical instrument adapter), laser probe, handheld laser sight, foot switch and automatic positioning device. It is used for navigation and orientation of neurosurgical instruments and implants.
The product mainly adopts core technologies such as multi-modal image fusion, laser surface registration and automatic positioning device. It has automatic positioning device. It is a domestic first medical device with independent intellectual property rights, and its performance indexes have reached the international level of the same kind of device. The product can improve the operation efficiency on the basis of ensuring the positioning accuracy, and can realize the basic positioning of the manipulator
2 Implantable Electrical Spinal Cord Nerve Stimulation Electrodes
1 Implantable Electrical Spinal Cord Nerve Stimulation Extension Lead
One of the implantable spinal cord nerve stimulation electrode products is composed of implantable spinal cord nerve stimulation electrode, electrode fixing anchor, tunneling tool, analog electrode, surgical electrode channel, torque screwdriver and spare electrode fixing anchor. One of the implantable spinal cord nerve stimulation electrode products is composed of implantable spinal cord nerve stimulation electrode, electrode fixing anchor, tunneling tool, analog electrode, surgical electrode channel, torque screwdriver and spare electrode fixing anchor. The implantable spinal cord nerve stimulation extension lead is composed of extension lead, sleeve, backup screw, tunnel making tool and torque screwdriver. The above products are used in conjunction with the appropriate implantable spinal cord nerve stimulator for patients aged 18 and above (except pregnant women) for the adjuvant treatment of chronic intractable pain in the trunk and limbs.
Implantable spinal cord nerve stimulation electrode and implantable spinal cord nerve stimulation extension lead mainly adopt high-density connection and anti bending fatigue core technology, and use a new sandwich electrode fixing anchor, which can enhance the fixing force of the electrode and reduce the electrode displacement rate. It is the first medical device in China.
Implantable Rechargeable Spinal Cord Nerve stimulator
Implantable Spinal Nerve Stimulator
The above products are composed of pulse generator, torque screwdriver and sealing head. It is used in combination with the appropriate implantable spinal cord nerve stimulation electrode and implantable spinal cord nerve stimulation extension wire for patients aged 18 and over (except pregnant women) for the adjuvant treatment of chronic intractable pain in the trunk and limbs.
The core technologies of the above products mainly include adaptive stimulation technology, multi site synchronous stimulation technology, remote monitoring and program control technology. The implantable rechargeable spinal cord nerve stimulator has wireless charging technology. The product has complete independent intellectual property rights and belongs to the first medical device in China. The preset stimulation parameters can be automatically called according to the patient’s posture to make the patient achieve a satisfactory treatment state. With remote program control function, it can remotely adjust parameters and reduce the number of patients to and from the hospital.
BradyKnows can assist manufacturers in China entry, including facilities establishment, QMS compliance and local manufacturing，please do not hesitate to contact us at info@ inspirativemed.com if you have any interest in bringing your products into China.
