Hosted on MSN13d
FDA grants clearance to icotec’s BlackArmor implants to treat spinal infection
The Centers for Medicare and Medicaid Services (CMS) has approved the implants for New Technology Add-on Payment (NTAP).
Yahoo Finance15d
icotec Announces FDA clearance for Spinal Infection Indication with BlackArmor® Implants
In addition to the on-label designation, the FDA has also granted a Breakthrough Device Designation (BDD) for this indication across the entirety of icotec's BlackArmor® spinal stabilization ...
Pharmabiz13d
icotec gets US FDA 510(k) clearance for use of BlackArmor implants to treat de novo spinal infections
FDA clearance for the use of BlackArmor implants in the treatment of de novo spinal infections. icotec is honoured to be the first and only company in the United States with FDA 510(k) clearance for ...
Longview News-Journal15d
icotec Announces FDA clearance for Spinal Infection Indication with BlackArmor® Implants
EAST HARTFORD, Conn., Jan. 14, 2025 /PRNewswire/ -- icotec is proud to announce that it has received FDA clearance for the use of BlackArmor® implants in the treatment of de novo spinal infections.