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FDA clears SURGIMAP 2.0 software

NEMARIS announced the company has received 510(k) clearance from the US Food and Drug Administration (FDA) for the next-generation SURGIMAP 2.0 platform, the preeminent software used to preoperatively plan spine surgery which now offers advanced tools based upon algorithms and the most recent scientific data on the parameters necessary to determine and restore optimal spinal alignment for each patient.

The latest release of SURGIMAP 2.0 features case and image sharing across users facilitated through cloud services as well as multiplatform functionality among PC and Mac operating systems. SURGIMAP 2.0 is used by over 2,000 surgeons worldwide.

The software was developed by a group of surgeons, engineers, business leaders, software experts and programmers in order to address the physician need for a user-friendly clinical imaging tool dedicated to spine.

"We are proud to reach this FDA approval milestone as our new platform offers the market’s first pre-operative planning software for custom spinal implants," said Virginie Lafage, PhD, Co-founder of NEMARIS.

"We created this software to provide surgeons with a clinical tool to plan, measure and review their results based upon the most current clinical data and algorithms. Our new 2.0 generation software allows for specific cases and images to be shared between surgeons, furthering the education and expertise of the collective group to improve patient outcomes."

SURGIMAP 2.0 includes the UNiD plug in, jointly developed with one of the company’s strategic partners, MEDICREA, (Alternext Paris: FR0004178572-ALMED), a company that specializes in the development of innovative surgical technologies for the treatment of spinal pathologies.

The UNiD plug in is embedded into the SURGIMAP 2.0 software interface, and provides surgeons a quick and efficient option for planning and ordering the UNiD rods, the world’s first patient-specific spinal osteosynthesis rods, currently available in Europe.

MEDICREA’s UNiD rod tool eliminates the need to manually contour the rods in the operating room, providing surgeons with a patient specific rod prior to surgery, thus optimizing clinical outcomes and reducing the amount of time patients spend in the operating room.

Once the surgery planning is complete, the order is transferred to MEDICREA’s UNiD Lab, which processes the request and industrially produces and labels the rod specifically for each patient.