Software Designed for the Assessment of Orthopedic Implant Fixation and Bone Segment Motion

The software is the first to measure the in vivo three-dimensional (3D) position and/or relative motion of metal implants, markers beads, and/or bone segments in 3D from calibrated stereo X-ray images.

When interpreted by trained physicians these measurements may be useful to derive conclusions for critical patient treatment decisions. Halifax Biomedical, Inc. (HBI; Mabou, NS, Canada), a company specializing in precision assessment of spine and joint-replacement microinstability, reported that their image processing software has received US Food and Drug Administration (FDA) clearance.

The MBRSA software has been developed and maintained by HBI partner RSAcore of the department of orthopedics at Leiden University Medical Center (LUMC; The Netherlands). “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,” said Chad Munro, chief executive officer for HBI.

“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,” said Chad Munro, chief executive officer for HBI.

“The FDA clearance of this analytical software is not only a major milestone for HBI but also for the orthopedic community as we shift toward broad clinical use in the United States. The HALIFAX program now includes FDA clearance for Halifax intraoperative bone markers, Halifax SR imaging systems, and now, SR image processing services,” said Crystal Jones, VP operations for HBI.

“This approval represents an important step forward in independent and quantitative assessment of orthopedic patients,” said Bart Kaptein, MSc, PhD, and Prof. Rob Nelissen, MD, PhD, of the department of orthopedics at LUMC. “MBRSA is a leading edge analysis platform, we are proud of the many years of intense research and development at LUMC to create this orthopedic research tool.”

Related Links:
Halifax Biomedical
Leiden University Medical Center