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Reimbursement / Regulatory

Medicrea Gains Additional FDA Clearance for Surgical Planning Software -

Medicrea gained FDA 510(k) clearance to integrate a complete database of implants into its UNiD HUB™ surgical planning software, to directly simulate and select implants prior to a procedure. This allows every implant to be planned prior to surgery, leaving staff to focus on inter-op care rather than excess inventory. It also yields savings in cost and human effort required to complete reprocessing and sterilization of a spine system, due to a reduction in the number of trays needed. In beta launch, pre-operatively measuring the patient’s pedicle diameter and length reduced shipped inventory by 70%. Further benefits of the database integration will support the ability to perform comprehensive patient-specific preoperative planning that can more completely link implant selection with post-op analyses, and increase the robustness and efficiency of Medicrea's proprietary predictive model. (Medicrea, 4/18/19)