France’s Biospace Medical gets FDA OK for X-ray station

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.

Biospace officialssaid 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 thesterEOS 2D/3D workstation.