Biospace Medical says received regulatory clearance to use its full-body, low-radiation X-ray workstation for children with spinal problems.
The Paris, France-based company, which houses its U.S. headquarters in Cambridge, Mass., won 510(k) clearance from the Food & Drug Administration to use its sterEOS 2D/3D workstation in pediatric care.
The device, which consists of a scanner and a three-dimensional bone-modeling program, can capture head-to-toe images of patients in a standing, weight-bearing position, which can help orthopedic surgeons determine balance, posture and the position of each vertebra. The company says the workstation enables better assessments for surgical planning.
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Biospace officials said the imaging device emits much smaller amounts of radiation than conventional x-rays and nearly 1,000 times less than a computed tomography scan, which they said is advantageous for children who suffer from scoliosis or other types of musculoskeletal disorders that require regular X-rays.
The firm already had clearance to use the device in adults, but said the opening of the pediatric market would help drive wider adoption of the sterEOS 2D/3D workstation.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
