Inossia receives US FDA Breakthrough Device Designation
Stockholm, July 1, 2025 – Inossia AB is proud to announce today that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Inossia® Cement Softener for use with PMMA bone cement in percutaneous vertebral augmentation procedures. This is an important step in Inossia’s regulatory plan and supports the planned 510(k) submission. […]
