Halifax Biomedical receives FDA Clearance for GE Healthcare XR656+ Halifax Radiostereometry Upgrade
HALIFAX Radiostereometry technology adds to GE healthcare’s XR656+ imaging unit to provide ultra-high precision in vivo 3D measurements.
Mabou, Nova Scotia -- Halifax Biomedical Inc. (HBI) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its HALIFAX RADIOSTEREOMETRY UPGRADE (K182880). The HALIFAX UPGRADE technology adds to GE Healthcare’s Discovery XR656/XR656 Plus x-ray imaging units to provide ultra-high precision in vivo 3D measurements.
The HALIFAX RADIOSTEREOMETRY UPGRADE is the first product to be launched under a joint development agreement between Halifax Biomedical Inc. and GE Healthcare. The HALIFAX UPGRADE is now available for sale to current GE XR656 customers in the U.S.
The HALIFAX Radiostereometry procedure requires taking two simultaneous x-rays of the patient anatomy from two different views. The HALIFAX UPGRADE comprises an L-arm imaging device with an x-ray tube that synchronizes with the XR656 x-ray tube and GE state-of-the-art imaging plates to take two high quality digital x-rays at the same time. The HALIFAX UPGRADE system takes up minimal floor space and can be quickly and easily positioned to perform both standing and table HALIFAX exams. Very precise HALIFAX calibration hardware is integrated into the L-arm. Specialized image processing software uses the calibration hardware as a reference for precise 3D measurement of bone and implant positions within the body. HALIFAX Radiostereometry exams have a 3D precision in the range of 0.05mm. This precision is many times better than current conventional CT imaging technology.
HALIFAX Radiostereometry has proven to be a powerful research tool in orthopedics. Research use includes phased innovation, which is the process of validating performance of new orthopedic products through rigorous clinical trials before broad market release. HALIFAX Radiostereometry has also shown great promise as an emerging clinical tool in areas such as evaluation of painful joint replacements and spine instability in chronic low back pain patients.
HBI’s turnkey approach makes it easy for leading orthopedic centers to implement high quality Radiostereometry-based orthopedic research and clinical monitoring programs. Centralized image processing is performed by experienced Halifax Biomedical analysts. The HALIFAX Radiostereometry Upgrade can integrate seamlessly into any one of several thousand existing installations of GE Healthcare’s XR656Plus imaging systems. Integrating into existing GE installations leverages previous capital investments while maintaining familiar digital x-ray workflow with excellent image quality.
“Halifax Biomedical is excited to offer this unique product upgrade for the GE XR656 imaging systems,” said Chad Munro, CEO of Halifax Biomedical Inc. “This is the highest quality, most efficient and most adoptable system we have created to date. This product launch is a major step towards creating an expanded network of leading orthopedic researchers to advance radiostereometric orthopedic research and clinical care.”
About HBI:
Halifax Biomedical Inc. (HBI) is an orthopedic measurements company headquartered in Nova Scotia, Canada and is a leading provider of HALIFAX Radiostereometry imaging technology. HBI focuses on two clinical problems: early detection of implant loosening for hip and knee joint replacements, and quantification of instability of the spinal column in patients with chronic low back pain. Products provided by HBI to support HALIFAX Radiostereometry include surgical bead inserters, implantable 1mm tantalum beads, HALIFAX Radiostereometry Upgrade imaging equipment, and centralized image processing services. The processing of joint replacement images is performed by HBI’s image analysis experts. Image processing is done using Model-based RSA software developed by HBI’s partner RSAcore, Leiden University Medical Center, The Netherlands.
About GE:
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
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