On May 16, 2023, the NMPA granted innovation approval to Conavi Medical Inc., from Canada, for its intravascular imaging system.
It is the fourth imported innovative device approved by the NMPA so far in 2023, after Medtronic, Alcon, and Ubiosis’ approvals. Read more information about innovation approvals this year.
There have been 199 innovation devices approved since 2014. To get an English copy of innovation devices catalog, please email info@ChinaMedDevice.com.
We have also translated the Innovation Device Approval Procedure for you, available for download.
What is the Intravascular Imaging Innovation Device?
The NMPA says in the notice that, “the product consists of a console (ADM) and a patient interface module (PIM) in conjunction with a single-use intravascular imaging catheter connection for intravascular imaging of coronary arteries during percutaneous coronary interventions.
“The imaging catheter is equipped with an acoustic probe and an optical probe at the far end, which can automatically acquire images and feed them back to the image processing module to achieve synchronous registration of intravascular ultrasound and optical interference tomography.
This product is superior to similar marketed products and can realize the above two imaging at the same time, synchronously meet the doctor’s requirements for resolution and penetration, simplify the doctor’s operation, and improve the accuracy and safety of imaging.”