The approval marks a significant shift for the Altstätten-based company, which previously secured Breakthrough Device Designation for the same technology in April 2025. By utilizing proprietary BlackArmor Carbon/PEEK materials, the system avoids the interference typically associated with metallic implants, allowing surgeons to conduct clearer X-ray, CT, and MRI scans postoperatively.
CEO Christoph Eigenmann noted that the CMS recognition provides clinicians with a clearer path to integrate the system into standard care. Beyond its imaging advantages, the CMORE CT system stands out as the only posterior cervicothoracic implant currently cleared by the FDA for treating spinal infections. While the NTAP designation offers financial support for qualifying procedures, the company clarified that final reimbursement remains subject to specific CMS and payer criteria.




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