FDA Clears Spine Surgery Software

The Food and Drug Administration has approved, with its 510(k) clearance, the next generation Surgimap 2.0 platform, made by Nemaris Inc. The Surgimap software, according to the company’s press release, serves more than 2, 000 spine surgeons worldwide.

“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 Co-founder Virginie Lafage, Ph.D. “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, a program jointly developed with Medicrea, one of Nemaris’ strategic partners. Medicrea 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 option for planning and ordering the UNiD rods. The rods are the world’s first patient-specific spinal osteosynthesis rods, according to Medicrea. They are currently available only in Europe.

According to company officials, 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 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 produces and labels the rod specifically for each patient.

Denys Sournac, chairman and CEO of Medicrea said, “Medicrea’s collaboration with Nemaris Inc. is an important step forward and brings spine surgery to a new era of personalized medicine, by combining Surgimap 2.0 innovative software platform for pre-operative planning with our rod customization and pedicle screw selection hardware solution. This FDA approval of Surgimap 2.0 software represents a significant step in the regulatory process towards UniD Rods implants’ clearance in the United States. Our partnership with Nemaris has already produced tremendous results in Europe with very positive feedback from surgeons and we look forward to our patient–specific rods becoming available in the U.S. in the near future.”