Sam Brusco, Associate Editor12.22.21
Home infusion solutions developer KORU Medical earned FDA 510(k) clearance expanding on-label use of the FREEDOM60 Infusion System to two subcutaneous Ig (SCIg) medicaltions, Cutaquig and Xembify.
“We are excited to announce another milestone for KORU Medical as we seek to further improve patients’ quality of life through the development and delivery of high-quality therapeutic drug delivery in the home,” Linda Tharby, president and CEO told the press. “Having the FREEDOM60 Infusion System cleared for use with Xembify and Cutaquig allows patients and providers additional options for life enhancing subcutaneous immunoglobulin therapy treatment in the home with a system that has broad patient and healthcare worker adoption. KORU Medical’s Freedom Infusion System is specifically cleared for use with more SCIg drugs than any other system. Adding Xembify and Cutaquig to our label, in addition to our recent FDA 510(k) clearance for use of Hizentra prefilled syringes with the FreedomEdge, extends KORU Medical’s leadership position in the growing SCIg market.”
“We are excited to announce another milestone for KORU Medical as we seek to further improve patients’ quality of life through the development and delivery of high-quality therapeutic drug delivery in the home,” Linda Tharby, president and CEO told the press. “Having the FREEDOM60 Infusion System cleared for use with Xembify and Cutaquig allows patients and providers additional options for life enhancing subcutaneous immunoglobulin therapy treatment in the home with a system that has broad patient and healthcare worker adoption. KORU Medical’s Freedom Infusion System is specifically cleared for use with more SCIg drugs than any other system. Adding Xembify and Cutaquig to our label, in addition to our recent FDA 510(k) clearance for use of Hizentra prefilled syringes with the FreedomEdge, extends KORU Medical’s leadership position in the growing SCIg market.”