Halifax Biomedical Inc. has received U.S. regulatory clearance to use its latest advanced imaging technology with x-ray equipment produced by GE Healthcare.
HBI, which is based in Mabou, Cape Breton, issued a press release Friday saying it has been granted 510(k) clearance from the U.S. Food and Drug Administration for its Halifax Radiostereometry Upgrade.
Hospitals add this technology to GE Healthcare’s Discovery XR656/XR656 Plus x-ray imaging units to provide ultra-high precision 3D measurements in orthopedic procedures like hip replacements.
The announcement comes about a year after HBI announced it had struck a deal with the medical equipment unit of General Electric, one of the world’s biggest medical equipment companies. The product announced on Thursday is the first to be launched under the partnership.
“Halifax Biomedical is excited to offer this unique product upgrade for the GE XR656 imaging systems,” said CEO Chad Munro in the statement. “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.”
The Halifax Radiostereometry procedure takes two x-rays of the patient from two different views at the same time. The new upgrade comprises an L-shaped arm imaging device that synchronizes with the main imaging machine to take two high-quality digital x-rays at the same time. It takes up minimal floor space and can be quickly positioned to perform both standing and table exams, said the statement.
Halifax Radiostereometry exams have a 3D precision in the range of 0.05 millimeters – many times better than current conventional CT imaging technology.
Specialists use the system for such things as phased innovation, which is the process of validating performance of new orthopedic products through rigorous clinical trials before broad market release. The system has also shown great promise as an emerging clinical tool in areas such as the evaluation of painful joint replacements and spine instability in chronic low back pain patients, said HBI.