Medicrea Gains Additional FDA Clearance for Surgical Planning Software

By Julie A. Vetalice

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.

Referring to beta phase use of the database with UNiD HUB, Denys Sournac, President and CEO, said, “[When a set is] loaned for a specific surgery, less than 10% of the inventory shipped is implanted in the patient. By pre-operatively measuring the patient’s pedicle diameter and length, we were able to reduce by 70% the amount of inventory being shipped. Similarly, in hospitals where inventory is consigned, we were able to optimize the number of implants and observed a reduction of inventory of 80% during the beta phase."

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.

Source: Medicrea

Product Labels: Surgical Planning

Tags: 510(k) Clearance, Regulatory