Amber Implants VCFix® spinal system obtains US FDA Breakthrough designation
On October 05, 2021, the US Food and Drug Administration (FDA) granted the Breakthrough Device Designation to VCFix® spinal system, a next-generation spinal implant for spinal injuries developed by Amber Implants, a Netherlands-based company.
Dr. Banafsheh Sajadi, Founder and CEO of Amber Implants, said that receiving the US FDA Breakthrough Designation is a significant recognition that will boost their efforts to bring VCFix® to patients. This development expedites their timeline significantly, with their First-In-Human clinical trial anticipated to start in early 2022 in Eu...
