Bairen Medical announced that the minimally invasive, suture-free aortic valve system for Class III medical devices independently developed by the company was approved by the Medical Device Technical Evaluation Center of the State Drug Administration and entered a special review process for innovative medical devices. The product complements the company's layout in the field of minimally invasive aortic valve replacement and no stitches. It can solve serious PPM problems in patients with aortic root stenosis, and is expected to shorten the registration cycle. However, the product still needs to be reviewed and approved before it can be marketed, and there is uncertainty about the impact on the company's recent performance.

Zhitongcaijing · 2d ago
Bairen Medical announced that the minimally invasive, suture-free aortic valve system for Class III medical devices independently developed by the company was approved by the Medical Device Technical Evaluation Center of the State Drug Administration and entered a special review process for innovative medical devices. This product complements the company's layout in the field of minimally invasive aortic valve replacement and no stitches. It can solve serious PPM problems in patients with aortic root stenosis, and is expected to shorten the registration cycle. However, the product still needs to be reviewed and approved before it can be marketed, and there is uncertainty about the impact on the company's recent performance.