The NMPA granted Innovation Approvals to two pieces of equipment in April 2022:
- Radiology: Magnetic resonance imaging system
- Orthopedic: Hip replacement surgery navigation and positioning system
NMPA issued the list of 151 innovation approvals since the pathway established in 2014. For an English copy of the list, please email us at info@ChinaMedDevice.com
Why Innovation Approvals NMPA April Are Approved
NMPA gives explanations for each approval:
Magnetic resonance imaging system
The product is composed of superconducting magnet (1.5T), scanning bed, spectrometer, radio frequency system, gradient system, operating table, isolation transformer, transmitting coil, gradient coil, respiratory gating, and radio frequency receiving coil for clinical MRI image diagnosis.
The main innovation of this product is the use of liquid helium-free superconducting magnet technology, which uses a refrigerator for direct conduction cooling. Compared with the conventional superconducting magnetic resonance products that use liquid helium to cool the superconducting coils in the magnets, the cost of production and usage is lower, the structure of the magnets is be simplified, and the weight of the magnets is reduced.
Hip replacement surgery navigation and positioning system
The product consists of a robotic arm system, an optical positioning system, a navigation control system, preoperative planning software, a foot switch, an encryption device, and accessories. For use only with proven hip prostheses and surgical tools for navigational positioning of surgical tools and hip prostheses during adult hip replacement surgery.
The core technologies of this product mainly include technologies such as spatial registration, robotic arm control, and safety boundary control. In hip replacement surgery, its degree of freedom robotic arm is used and has the function of safety boundary control, assisting doctors to complete acetabular grinding, femoral osteotomy, hip joint prosthesis installation, etc. Compared with traditional artificial hip replacement surgery, it ensures the accuracy of surgical positioning, reduces the probability of adverse events and complications, and reduces the radiation damage from X-rays to doctors and patients.