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Halifax Biomedical gets FDA clearance for image processing software

Halifax Biomedical Inc. recently announced in a press release that their new model-based RSA image processing software has received FDA clearance.

Developed and maintained by RSAcore of the Department of Orthopaedics at Leiden University Medical Center, 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 3D from calibrated stereo X-ray images.

“Our strong and longstanding 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,” Chad Munro, the chief executive officer of Halifax Biomedical Inc., stated in the press 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.”