FDA Expands Clinical Clearance for Spine Movement Recording System Vimove

Medical device company dorsaVi Ltd. has received 510(k) clearance from the U.S. Food and Drug Administration expanding the use of Vimove in the United States. Vimove is a system of wearable sensors for measuring, recording, and reporting on movement and muscle activity of the lumbar spine region. Vimove was previously cleared in July last year; this latest clearance improves the clinical capabilities of the system.

The expanded functionality and labeling permits the use of Vimove to display lower back and pelvic range of motion from healthy patients for the first time in the United States. Clinicians and their patients will now be able to compare how their movements are tracking against a “normal” population based on their age group, and help guide therapy decisions and rehabilitation accordingly.

Importantly, this new expanded labelling also permits dorsaVi to record, assess and report on additional static postures including lumbar lordosis (natural standing posture) and on various sitting postures. The inclusion of the pelvic movement data allows clinicians to independently isolate lumbar spine and pelvic movements.

As part of the submission to achieve the new labeling, the Vimove data was validated against sophisticated optical tracking sensors (Vicon) used in biomechanical laboratories, and with a marker set clinically validated against magnetic resonance imaging (MRI) for a range of lumbopelvic movements. All Vimove data for standing and sitting postures was accurate to within five degrees, the company claims.

“This is an important breakthrough for clinicians and patients,” said Andrew Ronchi, CEO of Dorsavi.

“510(k) clearance by the FDA, which enables the expanded use of Vimove in the United States, is a major milestone for dorsaVi and will allow us to increase our marketing efforts to physical therapists and health care professionals globally,” added John Kowalczyk, president of dorsaVi USA.

DorsaVi is headquartered in Melbourne, Australia, with U.S. offices in Plymouth, Mass.