FDA Approves Image Processing Software from Halifax Biomedical

The U.S. Food and Drug Administration (FDA) has approved new model-based RSA (Roentgen stereophotogrammetric analysis) image processing software from Halifax Biomedical Inc. (HBI).

Developed and maintained by RSAcore of the Department of Orthopaedics at Leiden University Medical Center in Leiden, the Netherlands, model-based RSA (MBRSA) software is an analytical software package for evaluation of orthopedic implant fixation and bone segment motion. It measures the in-vivo 3-D position and relative motion of metal implants, markers beads, and bone segments in 3-D from calibrated stereo X-ray images.

“Our strong and long-standing partnership with Leiden University Medical Center has enabled us to complete the final regulatory step in our transition from clinical research use of our technology to everyday clinical use,” Halifax Biomedical CEO Chad Munro said in a news release. “This FDA clearance will enable HBI to provide image processing services for two key clinical issues: deciding whether to intervene to stabilize a total knee replacement due to implant fixation concerns and deciding whether sufficient spine instability is present to justify spine fusion surgery.”

Halifax Biomedical Inc. is an orthopedic clinical measurements company headquartered in Nova Scotia, Canada, with a U.S. office located in Cambridge, Mass. The company also provides micro-instability assessment services.